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U.S. Department of Health and Human Services

Enforcement Report - Week of November 25, 2015

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Veterinary BAYER Spectam Injectable (spectinomycin) 100 mg/ml, packaged in 500 ml rubber-stopped glass bottles, Net Contents: 500 ml (NDC 0859-2383-01), NADA 040-040. The responsible name on the firm is Bayer HealthCare, Shawnee Mission, KS 66201. Product of China. Lot: 634238 Exp. 6/30/2016 Class II Product did not meet stability specifications; an out of specification result was reported for a known impurity at the 6 month time point. Bayer Healthcare Animal Health Inc
Devices GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery Lot: 145129 Class II Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws instead of 10 mm screws. Medacta Usa
Devices BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2.1, and Spine and Trauma 3D versions 2.0 and 2.1 An intraoperative image-guided localization system to enable minimally invasive surgery. Model/catalogue numbers: 19060 AIR ICT S&T W/O G.C. NEUROLOGICA BODYTOM; 19065 MOBILE iCT AUTOMATIC IMAGE REG. CRANIAL. Potentially affected is the integration of the NeuroLogica BodyTom portable CT scanner for automatic registration with Brainlab Navigation devices (Cranial / ENT version 2.1 and Spine & Trauma 3D versions 2.0 and 2.1) Class II Instances of data sets not being accurately registered to the patient anatomy were observed. Brainlab AG
Devices Prism Medical C-300 Consumer Ceiling Lift; PN 330050, 330050R, 330053, 330053R, and 330057; weight specification 300 lbs. /136 kg. Lifting aid used by health care professionals to lift, position, and transfer clients or disabled family members. All serial numbers produced since October 2011. Part 330050: SN C303094 C303510 C303374 C303922 C303924 C303925 C303257 C303386 C303223 C303264 C303492 C303239 C303352 C303326 C304076 C303429 C303847 C303457 C303065 303333 C303095 C303136 C303149 C303158 C303190 C303194 C303168 C304108 C303481 C303907 C303430 C303349 C303301 C303302 C303195 C303378 C303897 C303271 C303159 C303362  ...
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Class II Drive shaft and over speed arm may simultaneously fail potentially resulting in a patient falling during use ErgoSafe Products, LLC (DBA) Prism Medical
Devices Prism Medical P-300 Portable Consumer Lift; PN 303050, 303050R, and 303051; weight specification 300 lbs. /136 kg. All serial numbers produced since October 2011. Part Number 303050: SN P303885 P305001 P303816 P303948 P304050 P304745 P303670 P303783 P303822 P304003 P303999 P303675 P303342 P303351 P303519 P303690 P303784 P304045 P303405 P305150 P303741 P303825 P303916 P304732 P303595 P303850 P304597 P304606 P305056 P305095 P303547 P304715 P305040 P304598 P303458 P303945 P304012 P304016 P304438  ...
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Class II Drive shaft and over speed arm may simultaneously fail potentially resulting in a patient falling during use ErgoSafe Products, LLC (DBA) Prism Medical
Food Italian Green Beans. Product is IQF frozen, not ready to eat, each label carries cooking instructions. Packages sizes: 14 oz.; 16 oz.; 2 lbs.; 2.5 lbs.; 20 lbs. and 1,350 lbs. (tote) Product is sold under brands: Birds Eye (C&W), Markson First Crop, Bountiful Harvest, River Valley, Simplot Classic, Sysco Classic, Sysco Imperial, National, Monarch, Valamont, Worlds Finest, Tasteful and totes . Labels read in part: Item # 70332-00052 (not on label). "***BIRDS EYE C&W ***cut italian green beans***14oz***(UPC) 0 70332 00052 8***" Proof, of bag label. provided. Shipper case UPC Code 10070332000525. Item # 23234-13195 (not on label). "***12/2 LB***334400***MARKSON FIRST CROP*** Case label and proof of generic bag label provided. Generic labels are stamped with Net Wt. during production. No UPC Code - Generic Bag; Shipper Case UPC Code 10723234131957. Item # 22486-11893 is contained on case label "***12/2.5 LB BAGS NET WT. 30 LBS***22486***11893***1614***Bountiful Harvest Originals ITALIAN GREEN BEANS******" Case label and bag label provided. No UPC Code - Generic Bag. Shipping Case UPC Code 30822486118939. Item # 78982-00445-2 not on bag. "*** RIVER VALLEY*** Italian Green Beans NET WT. 16 OZ.***(UPC) 0 78982 11445 2***". Bag label provided. Shipping Case UPC Code 78982114452. Item # 71179-18052 not on bag/box. "***12/32 OZ BAGS***10071179180524***SIMPLOT CLASSIC ITALIAN BEANS***". Case label and a generic Simplot proof label for bag provided. There is no UPC on generic bag; Shipping Case UPC Code 10071179180524. Item # 74865-07851 not on label. "***Classic SYSCO ***Italian Cut Green Beans*** NET WT 32 OZ (2 LBS)***". Proof of bag and case label provided. No UPC Code-Generic Bag. Shipping Case UPC Code 1007117918052. Item # 74865-38722 "*** Imperial SYSCO ***FRESH FROZEN ITALIAN BEANS 6409577***" 12/2 LB. stamps applied, case and partial copy of bag labels provided. UPC for bag 74865-38722, Shipping Case UPC Code 10074865387221. Item # 74865-07851 "***Classic SYSCO***Fresh Frozen Italian Cut Breen Beans***NET WT 32 OZ (2 LBS)***(UPC) 0 74865 07851 1***" Proof of bag label provided. Shipping Case UPC Code 10074865078518. Item # 72608-30730. "***FROZEN ITALIAN BEAN MIXED CUTS DISTRIBUTED BY NATIONAL FROZEN FOODS CORPORATION SEATTLE, WA 98109***" 20 LB NET WT. ; case label provided. Blue liner used, no UPC for liner. Shipping Case UPC Code 7260830730. Item # 58108-00504. "***MONARCH***ITALIAN GREEN BEANS***NET WT/PESO NETO 32 OZ (2 LB)***(UPC) 7 58108 00504 4***". Proof for bag label provided. Shipping Case UPC Code 50758108005049. Item # 72608-12284 for 12/2 and item # 72608-12288 for 20 lb. case. "***FROZEN VALMONT ITALIAN BEANS ***" 12/2 LB case and 20 lb; case labels provided. In the 20 lb case a generic blue bag is used. In the 12/2lb product clear plastic bags are used. Photos of the bags were provided. 12/2 Case UPC Code 10072608122849. 20 lb Case UPC Code 00072608122880. Item # WFN99-11200. "***C.H. BELT'S WORLDS FINEST Italian Cut Beans***NET WT. 91 KG (2 LBS) 32 OZ*** (UPC)8 82240 00004 6***". Partial label of bag and proof of label provided. Shipping Case UPC Code 10882240000043. Item # 72608-30605. "***72608***30605***12/2 LBS***TASTEFULL ITALIAN BEANS ***" Case label and photo of product inside case were provided. There is no labeling on bags, they are clear poly. Shipping Case UPC Code 7260830605. Totes IT BEAN R/C - have a sticker. The one for FSUP-111-110, 111-720, 111-136 were provided. All are 1350 lbs. There are no UPC codes. LOT NUMBERS: Item # 70332-00052 - 29216-KA23076A31, expiration date 7/23/2016. Item  ...
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Class II Italian Green Beans product is recalled due to potential to be contaminated with Listeria monocytogenes. National Frozen Foods Corporation--Seattle
Food Italian Blend. Product is IQF frozen, not ready to eat, each label carries cooking instruction. Label reads in part: "*** market pantry *** STEAM-IN-BAG Italian-Style Blend Broccoli, Cauliflower, Carrots, Italian-Style Green Beans & Zucchini*** NET WT 12 OZ***(UPC) 0 85239 90084 0***" Shipper Case UPC Code 10085239000847. Proof of bag label provided. This product is produced solely for Target stores. Item # 85239-90084-1 - lot numbers 29220-4G24F3N, 29220-4G24G3N, 29220-4G24H3N, 29220-4G24J3N, 30445-5A15C3N, 30445-5A15D3N, 30516-5A22K3N, 30516-5A22L3N, 30581-5A29K3N, 30581-5A29L3N, 31046-5C24F3N, 31046-5C24G3N, 31046-5C24H3N, 31046-5C24J3N, 31046-5C24K3N, 31046-5C24L3N, 31046-5C24M3N, 31087-5C30J3N, 31087-5C30L3N, 31087-5C30M3N, 31095-5C31B3N, and 31095-5C31C3N with corresponding expiration dates7/24/2016, 7/24/2016, 7/24/2016, 7/24/2016, 1/15/2017, 1/15/2017, 1/22/2017, 1/22/2017. 1/29/2017, 1/29/2017, 3/24/2017, 3/24/2017, 3/24/2017, 3/24/2017, 3/24/2017, 3/24/2017, 3/24/2017,  ...
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Class II Italian Blend product is recalled due to potential to be contaminated with Listeria monocytogenes. National Frozen Foods Corporation--Seattle
Food Italian Blend. Product is frozen, not ready to eat, label carries cooking instruction. Label reads in part "***FIRST STREET***ITALIAN BLEND CARROTS, CAULIFLOWER, ITALIAN GREEN BEANS, ZUCCHINI, LIMA BEANS*** NET WT 32 OZ***" UPC on bag 041512081958; Shipping Case UPC Code 47203. Copy of photo of bag label provided. Item # 41512-08195 - 30524-5A22B3N, 30896-5C05C3N, 30896-5C05D3N, 30896-5C05E3N, 31099-5C31G3N, and 31099-5C31H3N with corresponding expiration dates 1/22/2017, 3/5/2017, 3/5/2017, 3/5/2017, 3/31/2017, and 3/31/2017. Class II Italian Vegetable Blend product is recalled due to potential to be contaminated with Listeria monocytogenes. National Frozen Foods Corporation--Seattle
Food Italian Vegetable Blend. Product is frozen, not ready to eat, label carries cooking instruction. Label reads in part "***SIMPLOT CLASSIC*** ITALIAN BLEND*** INGREDIENTS: ZUCCHINI, CARROTS, CAULIFLOWER, ITALIAN BEANS, LIMA BEANS, RED BELL PEPPER***" For 12/2 lb UPC on proof for bag 0 71179 18875 2. Shipping Case UPC Code 10071179188759. For 20 lb. case, a blue liner is used (no UPC), Shipping Case UPC Code 10071179188872. 20 LBS. NET WT case consists of one unmarked blue poly bag. 32oz (2 LBS) - case consists of 12/32oz packages Copy of proof for bag and proof for case label provided. 12/2lb - Item # 71179-18875 - LOT #'s 965DEC051403E, 965DEC051403F, 965DEC051403G, 965FEB041503C, 965FEB041503D, 965FEB041503E, 965FEB041503F, 965FEB251503E, 965MAR191504D, 965MAR311503J, 965MAR311503K, 965MAR311503L, 965MAR311503M, 965MAY281503G, 965MAY281503H, 965MAY281503J, and 965MAY281503K with corresponding expiration dates 12/5/2016, 12/5/2016, 12/5/2016, 2/4/2017, 2/4/2017, 2/4/2017 2/4/2017, 2/25/2017, 3/19/2017, 3/31/2017, 3/31/201, 3/31/2017, 3/31/2017, 5/28/2017, 5/28/2017, 5/28/2017, and 5/28/2017. 20lb - Item # 71179-18887 lot #  ...
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Class II Italian Vegetable Blend product is recalled due to potential to be contaminated with Listeria monocytogenes. National Frozen Foods Corporation--Seattle
Food Italian Vegetable Blend. Product is frozen, not ready to eat, label carries cooking instruction. Label reads in part "***Sysco Classic Italian Vegetable Blend***NET WT***2 LB***INGREDIENTS: Zucchini, Carrots, Cauliflower, Italian Green Beans, Baby Lima Beans***UPC 0 74865 01802 9***" Shipping Case UPC Code 10084765018026. Case label reads in part "***Sysco Imperial ITALIAN VEGETABLE BLEND***6/4 lb***INGREDIENTS: Zucchini, Carrots, Cauliflower Florets, Italian Beans, Lima Beans***" No UPC Code on inner generic bag; Shipping Case UPC Code 10074865024447. Classic 12/2lb - Item # 74865-01802, lot #'s 29347-4H14D3N, 30525-5A22C3N, 30525-5A22D3N, 30556-5A27D3N, 30734-5B13B3N, 30734-5B13C3N. 30734-5B13D3N, 30982-5C16D3N, 31191-5D09H3N, 31191-5D09J3N, and 31191-5D09K3N  ...
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Class II Italian Vegetable Blend product is recalled due to potential to be contaminated with Listeria monocytogenes. National Frozen Foods Corporation--Seattle
Food Italian Vegetable Blend. Product is frozen, not ready to eat, label carries cooking instruction. Label reads in part Item # 58108-03475 "***MONARCH***ITALIAN VEGETABLE BLEND CONTAINS ZUCCHINI, CARROTS, CAULIFLOWER, LIMA BEANS AND ITALIAN GREEN BEANS***NET WT***64 OZ***(UPC) 7 58108 03475 4***" Copy of photo of bag label provided. Product is packaged as 6/4 lb bags. Shipping Case UPC Code 5075808034759. Item # 72608-13991 "***12/2 LBS***72608***13991***VALMONT ITALIAN BLEND CONTAINS: ZUCCHINI, CARROTS, CAULIFLOWER, LIMA BEANS, ITALIAN BEANS***" Shipping UPC Case Code 1 00 72608 13991 5. Copy of case label provided. Item # 58108-03475 (Monarch)- lot #'s 30052-4L18C3N, 30170-4M03K3N, 30170-4M03L3N, 30170-4M03M3N, 30788-5B19G3N, and 30983-5C16F3N with corresponding expiration dates 11/18/2016, 12/3/2016, 12/3/2016, 12/3/2016, 2/19/2017, and 3/16/2017. Item # 72608-13991 - (Valmont) 29292-4H05B3N, 30733-5B13B3N, and 31098-5C31G3N with corresponding expiration dates 8/5/2016, 2/13/2017, 3/31/2017, . Class II Italian Vegetable Blend product is recalled due to potential to be contaminated with Listeria monocytogenes. National Frozen Foods Corporation--Seattle
Food Italian Vegetable Blend. Product is frozen, not ready to eat, label carries cooking instruction. Label reads in part "***MARKON FIRST CROP*** A proof of the label was provided, it does not contain product identity, net wt or ingredients. This product is available in two sizes, 12/2 lb or 20 lb. Copies of case labels were provided. Label reads in part "***20 KB NET WT. 349548 MARKON FIRST CROP ***ITALIAN BLEND CONTAINS: BROCCOLI, CAULIFLOWER, CARROTS, ITALIAN BEANS, LIMA BEANS,***(UPC) 0 07 23234 13245 2***" No UPC on blue liner. Shipping Case UPC Code 10723234132954. "***12/2 lbs 349547 MARKON FIRST CROP***ITALIAN BLEND CONTAINS: BROCCOLI, CAULIFLOWER, CARROTS, ITALIAN BEANS, LIMA BEANS***" No UPC on generic bags; Shipping Case UPC Code 10723234132954. Lot Code Information 20 LB - Item # 23234-13245 - 29097-4G02G3N and 30774-5B17M3N,with corresponding expiration dates 7/2/2016 and 2/17/2017. 12/2 lb - Item # 23234-13295 29568-4J18J3N, 29949-4L04D3N, 29949-4L04E3N, 30773-5B17K3N, and 30773-5B17L3N with corresponding expiration dates 9/18/2016, 11/4/2016, 11/4/2016, and 2/17/2017. Class II Italian Vegetable Blend product is recalled due to potential to be contaminated with Listeria monocytogenes. National Frozen Foods Corporation--Seattle
Food Italian Vegetable Blend. Product is frozen, not ready to eat, label carries cooking instruction. Label reads in part "***GARDEN FRESH***64775***47374***ITALIAN BLEND CONTAINS: ZUCCHINI, CARROTS, CAULIFLOWER, LIMAS, ITALIAN BEANS***20 LB NET WT***" No UPC on blue liner. Shipping Case UPC Code 6477547374. Product of (Country or Countries) is stamped on the case at the time of production. A label example stated product of USA/China. Photo of case label provided. Lot Code Information Item # - 64775-47374 - 29725-4K08D3N, 30604-5B03K3N. and 30604-5B03L3N with corresponding expiration dates 10/8/2016, 2/3/2017, and 2/3/2017. Class II Italian Vegetable Blend product is recalled due to potential to be contaminated with Listeria monocytogenes. National Frozen Foods Corporation--Seattle
Food Italian Vegetable Blend. Product is frozen, not ready to eat, label carries cooking instruction. Label reads in part Case"***Sysco Imperial ***FIESTA VEGETABLE BLEND***REORDER# ***8446007 *** 6/4 lb*** (UPC) 1 00 74865 52887 7***INGREDIENTS: Broccoli, Carrots, White Beans, Red Kidney Beans, Italian Beans, Garbanzo Beans, Red Peppers***" The inner bags are generic with no UPC code. Lot Code Information Item # 74865-02444 - 29748-4K07G3N and 30565-5A28K3N with corresponding expiration dates 10/7/2016 and 1/28/2017. Class II Italian Vegetable Blend product is recalled due to potential to be contaminated with Listeria monocytogenes. National Frozen Foods Corporation--Seattle
Food Cold Smoked Salmon Deli trays (CS300), 2 pcs, 3lbs/trays. 6lbs per case. Julian date:(lot#) 188 Class II Certified Smoked Fish is Cold Smoked Salmon because they have the potential to be contaminated with Listeria monocytogenes. Certified Smoked Fish LLC
Food Cold Smoked Salmon Trim (CST50), 2 pcs, 2.5 lbs/case. 5lbs per case. Julian date:(lot#) 188 Class II Certified Smoked Fish is Cold Smoked Salmon because they have the potential to be contaminated with Listeria monocytogenes. Certified Smoked Fish LLC
Devices Baxter's HomeChoice and HomeChoice Pro APD systems are designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients. Their Fill volumes can range from 60 mL to 3000 mL. The HomeChoice and HomeChoice Pro APD systems are intended to be operated by: -Home patients whose physicians have prescribed this system. Patients, or their caregivers, must have received adequate training to use the system. -Clinicians who are using the system for patients under their care and under a prescription. Clinicians must have received adequate training to use the system. Since drain and volume requirements vary among patients, both the HomeChoice and HomeChoice Pro APD systems have a choice of modes, either Standard Fill Mode (Standard Mode) or Low Fill Mode. The dialysis center selects the Fill mode for the patient before therapy begins. All HomeChoice and HomeChoice PRO devices. All LOT numbers and Serial number for Product Codes 5C4471, 5C4471R, 5C8310 and 5C8310R. Dates Distributed: 1994 to present Quantity Distributed: All Class III Loud operating sounds, which was unacceptable to the end users when the device was powered on. The HomeChoice devices continue to perform as intended, as the issue is only associated with the noise coming from the device and not the function of it. May delay treatment if changing to a different system. Baxter Healthcare Corp.
Drugs LiDa DAIDAIHUA (also packaged as LiDa DAIDAIHUAJIAONANG), capsules, packaged in 1.6oz box 30 capsules per box, Kunming Dali Industry & Trade Co., Ltd all lots Class I Marketed Without An Approved NDA/ANDA: presence of undeclared Sibutramine and Phenolphthalein. Blue Square Market, Inc.
Drugs KABOOM action strips, Sexual Performance Strips, packaged in 6.4oz box 12 strips per box, Nutrology USA LLC all lots Class I Marketed Without An Approved NDA/ANDA: presence of undeclared Sulfoaildenafil. Blue Square Market, Inc.
Food Frozen Peas & Carrots, Product is IQF, frozen, not ready to eat, each label carries cooking instructions. Product is packaged under the following brand names and sizes: 1. Bountiful Harvest, Net Wt.40 oz. (2.5 lbs.) 1.13 kg, UPC 22486-11902; 2. Giant Eagle, Net Wt 16 oz (1 lb) 454 g, UPC 30034-00993; 3. Our Family, Net Wt 16 oz (454 g), UPC 70253-10513; 4. Sysco Classic, Net Wt 40 oz (2.5 lbs) 1.13 kg, UPC 74865-07850. Bountiful Harvest: Packaging Code: PL25132 / Production Code: 1086893; Giant Eagle: Packaging Code: PL25125 / Production Code: 1086893 Best By 05/2014; Our Family: Packaging Code: PL35132 or PL45132 / Production Code: 1086893, Best By 05/2017 Sysco Classic: Packaging Code: PL25148 / Production Code: PLMB4305, Best By 05/2017 Class II The Ohio Department of Agriculture conducted testing on the product and found it positive for Listeria monocytogenes. Lakeside Foods, Inc
Food Cucumber, Super Select Unspecified variety packed in Hello Fresh box the week of August 24-28-2015 in the meal Spicy Tuna Tar-Tacos with Creamy Avocado and Cucumber Radish Slaw. 7-10 inches long, I cucumber per box. ASYS# 5901807; PSYS # 684780 Lot 201508 Class I Firm was notified by their supplier that cucumbers provided are under recall due to potential Salmonella contamination. Grocery Delivery E-Services USA, Inc.
Food Cucumber, sliced 3/8", product is packaged in a 2 lbs. plastic bag and placed in a cardboard box. Product is sold to deli department at retail store and it is not sold directly to consumers. The UPC is 0 45009 10104 4. GTIN# 1 0045009 10104 1, Use By dates include 8/8/15 and up to 9/11/15. Class I Cucumber, sliced 3/8", is recalled due to a potential contamination with Salmonella. Sliced cucumber is linked to the current recall of Limited Edition Brand Cucumbers being conducted by Andrew & Williamson Fresh Produce. Triple B Corporation
Food Raw cucumbers packaged in bulk in 6-count corrugated boxes bearing the Front Row Produce logo. There is no city or state listed on the label. Lot numbers X0039299, X0039348, X0039457, and X0039496. Class I Potentially contaminated with Salmonella Front Row Produce LLC
Food CU-W-Whole Cucumbers (1/6 CT Bag) KEEP REFRIGERATED Made by: Vaughan Foods, Moore, OK 73160; Whole Cucumbers 1/5-LB NET WT: 5 LB Distributed by: US Foods, Inc. Rosemont, IL 60018 PRODUCE OF USA & MEXICO item # 07419 and 09256; UPC code: 718129074191 and 718129092560 Class I Potential to be contaminated with Salmonella. Vaughan Foods
Food SK-TG-Timeless Garden Salad Kit (1/2.43 LB) KEEP REFRIGERATED Made by: Vaughan Foods, Moore, OK 73160 item # 07667; UPC code: 718129076676 Class I Potential to be contaminated with Salmonella. Vaughan Foods
Food Sliced Cucumbers (100/3 oz) KEEP REFRIGERATED Made by: Vaughan Foods, Moore, OK 73160; Sliced Cucumbers (50/3 oz) KEEP REFRIGERATED Made by: Vaughan Foods, Moore, OK 73160; CU-2-Sliced Cucumbers (1/5 LB Tub) KEEP REFRIGERATED Made by: Vaughan Foods, Moore, OK 73160 item # 07726, 07727, 06898; UPC code: 718129077260, 718129077277, 718129068985 Class I Potential to be contaminated with Salmonella. Vaughan Foods
Food Taboli Net Wt. 80 oz (5 lb/2.82 kg) KEEP REFRIGERATED Manufactured by Fresh Creative Foods, Inc. Moore, OK 73160 in plastic tub item # 04759; UPC code: 718129047591 Class I Potential to be contaminated with Salmonella. Vaughan Foods
Drugs ACETYLCYSTEINE 10% OPHTALMIC, 10 mL dropper bottle; For topical ophthalmic use, Rx.only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032. Lot Numbers: 20150209@41 BUD: 10/2/2015, 20150909@2 BUD: 10/9/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Alprostadil (PGE-1), 5 mL (40 mcg/mL) in 10 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC: 62295-3253-05. Lot Numbers: 20150408@10 BUD: 1/27/2015; 20151407@11 BUD: 1/10/2015; 20151604@8 9/16/2015; 20152703@2 9/16/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Betamethasone Combo 10 mL (7 mg/mL), 10 mL Multi-Dose Vial,for IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3018-10 Lot Numbers: 20150104@4 BUD: 9/27/2015; 20150105@1 BUD: 10/27/2015; 20150107@25 BUD: 12/27/2015; 20150306@44 BUD: 11/29/2015; 20150704@49 BUD: 10/3/2015; 20150705@5 BUD: 11/1/2015; 20151106@17 BUD: 12/7/2015; 20151305@5 BUD: 11/8/2015; 20151806@19 BUD: 12/13/2015; 20152005@29 BUD: 11/15/2015; 20152205@7 BUD: 11/16/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Betamethasone Combo PF 2 mL (6 mg/mL) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3018-02 Lot Numbers: 20150206@41 BUD: 11/28/2015; 20151603@58 BUD: 9/12/2015; 20152007@43 BUD: 1/16/2016; 20152104@41 BUD: 10/18/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Betamethasone SP, 2 mL (6 mg/mL),10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3240-07 Lot Numbers: 20150806@9 BUD: 12/5/2015; 20152107@38 BUD: 1/17/2016 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Betamethasone SP PF (12 mg/mL), 2 mL Single Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3016-02 Lot Numbers: 20150107@27 BUD:12/28/2015; 20150704@5 BUD: 10/4/2015; 20152005@22 BUD: 11/16/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Bi-Mix (Papaverine 30 mg/mL, Phentolamine 1 mg/mL), 5 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3254-05 Lot Numbers: 20152303@7 BUD: 9/19/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Brompheniramine Maleate (10 mg/mL), 10 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3019-07 Lot Numbers: 20151205@11 BUD: 11/7/2015; 20151806@11 BUD: 12/15/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Cyclo/PE/Trop PF (1%/2.5%/1%), 3 mL dropper bottle, For topical ophthalmic use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3049-03 Lot Numbers: 20150707@5 BUD: 1/3/2016 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Cyclo/PE/Tropic/Ketor (1%/2.5%/1%/0.5%), 10 mL Opthalmic dropper bottle, For topical ophthalmic use, Rx. only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3044-07 Lot Numbers: 20152707@22 BUD: 10/25/2015; 20150707@9 BUD: 10/5/2015; 20152906@15 BUD: 9/27/2015; 20152907@2 BUD: 10/27/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Cyclopent/PE/Tropic 2mL (1%/2.5%/0.25%), 2 mL dropper bottles; For topical ophthalmic use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3299-02 Lot Numbers: 20151806@22 BUD: 12/15/2015; 20152306@36 BUD: 12/20/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Dapiprazole (Diluent+Powder) 0.5% in 5 mL vial, For topical ophthalmic use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-0201-99 Lot Numbers: 20150506@6 BUD: 11/28/2015; 20150805@40 BUD: 10/31/2015; 20151206@7 BUD: 12/5/2015; 20151704@21 BUD: 10/10/2015; 20152003@43 BUD: 9/12/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Dex LA 8 (Dexamethasone acetate (8 mg/mL), 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3299-02 Lot Numbers: 20150107@23 BUD: 12/28/2015; 20151305@43 BUD: 11/9/2015; 20151307@18 BUD: 1/9/2016; 20152204@33 BUD: 10/19/2015; 20152606@1 BUD: 12/22/2015; 20153003@34 BUD: 9/26/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Dex Combo (Dexamethasone acetate 8mg/mL, dexamethasone sodium phosphate USP, 4 mg/mL),30 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3057-06 Lot Numbers: 20150705@1 BUD: 11/2/2015; 20151706@49 BUD: 12/14/2015; 20152204@21 BUD: 10/19/2015; 20152303@26 BUD: 9/19/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Dexamethasone Sodium Phosphate PF (10 mg/mL), 2 mL Single Use Vial, For IV or IM Use Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3227-02 Lot Numbers: 20151407@13 BUD: 1/10/2016 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs ePHEDrine Sulfate PF (50 mg/10 mL), 10 mL Single-Use Syringe, For IV or IM Use Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3084-07 Lot Numbers: 20151706@45 BUD: 12/14/2015; 20151707@16 BUD: 1/13/2016; 20150904@17 BUD: 10/6/2015; 20151703@19 BUD: 9/13/2015; 20153003@7 BUD: 9/26/2015; 20153006@42 BUD: 12/27/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Fentanyl PF 50 mL (25 mcg/mL), 10 mL Single Use Syringe, For IV, IM or SC injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-0002-50 Lot Numbers: 20150604@20 BUD: 10/3/2015; 20152306@20 BUD: 12/20/2015; 20152403@28 BUD: 9/20/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Glycopyrrolate USP ( 1 mg/5 mL), 5 mL Single Use syringe, For IM or IV Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3082-05 Lot Numbers: 20150306@57 BUD: 11/30/2015; 20151305@40 BUD: 11/9/2015; 20151404@36 BUD: 10/11/2015; 20151603@3 BUD: 9/12/2015; 20152005@40 BUD: 11/16/2015; 20153003@10 BUD: 9/26/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs HCG/B12 (5,000 units, 0.6 mg) 5 mL, Multi-Dose Vial, For IM or SC Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3083-99 Lot Numbers: 20150806@22 BUD: 12/5/2015; 20150106@12 BUD: 11/28/2015; 20150106@20 BUD: 11/28/2015; 20150604@2 BUD: 10/3/2015; 20150604@2 BUD: 10/3/2015; 20150607@9 BUD: 1/2/2016; 20150806@22 BUD: 12/5/2015; 20151304@13 BUD: 10/10/2015; 20151506@22 BUD: 12/12/2015; 20152007@4 BUD: 1/16/2016; 20152206@20 BUD: 12/19/2015;  ...
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Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Hyaluronic Acid/Lidocaine PF (20 mg/1%), 2 mL Single-Use Syringe , For Intra-Articular Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3087-02 Lot Numbers: 20150906@32 BUD: 12/6/2015, 20150906@33 BUD: 12/6/2015, 20151105@45 BUD: 11/7/2015, 20151205@12 BUD: 11/8/2015, 20151404@39 BUD: 10/11/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Hyaluronic Acid/Lidocaine PF (60 mg/2%), 3 mL Single Use Syringe, For Intra-Articular Injection , Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3249-03 Lot Numbers: 20151105@39 BUD: 11/7/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Hyaluronic Acid/Lidocaine (20 mg/1%/2 mL), 3 mL Single Use Syringe, For Intra-Articular Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3239-01 Lot Numbers: 20151806@30 BUD: 11/7/2015, 20152306@38 BUD: 11/7/2015, 20151806@29 BUD: 11/7/2015, 20151903@30 BUD: 9/15/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Hyaluronidase PF (150 units/mL) in 1 mL Single-Use Vial, Not for IV Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3239-01 Lot Numbers: 20150608@1 BUD: 10/5/2015, 20152707@4 BUD: 9/23/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Choline chloride 50 mg/mL, Inositol 50 mg/mL Cyanocobalamin 1000 mcg/mL, 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3294-06 Lot Numbers: 20150405@59 BUD: 10/31/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs L-Cysteine PF (50 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3239-01 Lot Numbers: 20151906@10 BUD: 9/17/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Lidocaine 1% PF(100 mg/10 mL),10 mL Single Use Syringe, For IV Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3099-07 Lot Numbers: 20150104@21 BUD: 9/28/2015, 20150406@26 BUD: 12/1/2015, 20151704@1 BUD: 10/14/2015, 20152004@10 BUD: 10/17/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Lincomycin/Lidocaine (300 mg/1%/mL), 10 mL Multi-Dose Vial, For IV Injection or IV Injection After Dilution, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3104-07 Lot Numbers: 20150505@1 BUD: 10/31/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs MedroxyPROGESTERone/Lidocaine (150 mg/mL/1%) 10 mL Multi-Dose Vial, For IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3113-07 Lot Numbers: 20150705@13 BUD: 11/3/2015, 20151805@36 BUD: 11/14/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Methylcobalamin (12.5 mg/mL), 2.5 mL Multi-Dose Vial, For IM or SC Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3251-04. Lot Numbers: 20152105@38 BUD: 11/17/2015, 20152705@34 BUD: 11/23/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs MethylPREDNISolone (100 mg/mL) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3115-07 Lot Numbers: 20150806@41 BUD: 12/5/2015, 20151205@67 BUD: 11/8/2015, 20151504@24 BUD: 10/12/2015, 20152306@30 BUD: 12/20/2015, 20152603@27 BUD: 9/22/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs MethylPREDNISolone PF (80 mg/mL), 1 mL Single Use Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3119-01. Lot Numbers: 20150806@35 BUD: 12/5/2015, 20151006@34 BUD: 12/7/2015, 20152303@42 BUD: 9/19/2015, 20152704@16 BUD: 10/24/2015, 20152906@26 BUD: 12/26/2015, 20153007@19 BUD: 1/26/2016, 20151703@6 BUD: 9/13/2015, 20151806@12 BUD: 12/15/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Methylprednisolone/Lidocaine (40 mg/mL/1%) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3122-07 Lot Numbers: 20150707@31 BUD: 1/3/2016, 20150707@36 BUD: 1/3/2016, 20151106@19 BUD: 12/8/2015, 20151604@24 BUD: 10/13/2015, 20151606@20 BUD: 12/13/2015, 20151805@60 BUD: 11/14/2015, 20152105@35 BUD: 11/17/2015, 20153103@13 BUD: 9/27/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs MIC Combo (Methionine 25 mg/mL, Inositol 50 mg/mL, Choline chloride 50 mg/mL, Cyanocobalamin 1000 mcg/mL), 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3127-06. Lot Numbers: 20150705@32 BUD: 11/2/2015, 20151304@17 BUD: 10/10/2015, 20151905@56 BUD: 11/15/2015, 20152004@9 BUD: 10/17/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs MIC-Combo, 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3127-06. Lot Code: 20150105@18 BUD: 10/28/2015, 20150805@34 BUD: 11/4/2015, 20152603@12 BUD: 9/21/2015, 20153004@20 BUD: 10/27/2015, 20150805@34 BUD: 11/4/2015, 20152603@12 BUD: 9/21/2015, 20153004@20 BUD: 10/27/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Morphine PF (2 mg/2 mL), 2 mL Single Use Vial, For IV or IM Administration, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-2171-02 Lot Code: 20151008@2 BUD: 2/6/2016, 20151307@2 BUD: 1/9/2016, 20153107@27 BUD: 1/27/2016 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Neostigmine (5 mg/5 mL), 5 mL Single Use Syringe, For IM, SC or Slow IV Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3132-05 Lot Code: 20150106@48 BUD: 11/28/2015, 20150106@49 BUD: 11/28/2015, 20150306@37 BUD: 11/30/2015, 20150906@50 BUD: 12/6/2015, 20150906@7 BUD: 12/5/2015, 20151208@32 BUD: 2/8/2016, 20152304@2 BUD: 10/20/2015, 20152804@6 BUD:10/24/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Omnipaque 300 (600 mg/2 mL), 2 mL Single Use Vial (300 mg/mL), For IV or IT Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3137-02 Lot Code: 20150604@4 BUD: 10/3/2015, 20152205@1 BUD: 11/18/2015, 20152303@3 BUD: 9/19/2015, 20150604@1 BUD: 10/3/2015, 20151304@27 BUD: 9/19/2015, 20151506@19 BUD: 12/12/2015, 20151506@27R BUD: 11/28/2015, 20151603@2 BUD: 9/12/2015, 20152004@13 BUD: 10/17/2015, 20152206@13 BUD: 12/19/2015, 20152906@7 BUD: 12/26/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Phenylephrine 1.5%/ Lidocaine 1%, 1 mL Single Use Vial, For Intracameral Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3155-01 Lot Code: 20151506@31 BUD: 9/13/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Phenylephrine 10% PF Ophthalmic Solution, 3 mL dropper bottle, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3273-03. Lot Code: 20151803@4 BUD: 9/14/2015, 20152005@19 BUD: 11/16/2015, 20152307@15 BUD: 1/19/2016, 20153003@4 BUD: 9/26/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Phenylephrine (1 mg/mL), 5 mL Multi-Dose Vial, For SC, IM, IV or penile injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3289-05 Lot Code: 20150904@11 BUD: 10/6/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Phenylephrine PF (1 mg/10 mL), 10 mL Single Use Syringe, For IV Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3159-07 Lot Code: 20150806@1 BUD: 12/5/2015, 20150806@2 BUD: 12/5/2015, 20151105@4 BUD: 11/7/2015, 20151105@6 BUD: 11/7/2015, 20151407@3 BUD: 1/10/2016, 20151603@1 BUD: 9/12/2015, 20151805@25 BUD: 11/14/2015, 20151805@28 BUD: 11/14/2015, 20152206@17 BUD: 12/19/2015, 20152707@1 BUD: 1/23/2016, 20153003@1 BUD: 9/26/2015, 20152003@2 BUD: 9/26/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Phenylephrine PF Sterile Solution (2.5%), 3 mL Single Use Ophthalmic Dropper For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3272-03 Lot Code: 20150206@3 BUD: 11/29/2015, 20150306@51 BUD: 11/30/2015, 20151106@28 BUD: 12/8/2015, 20151404@4 BUD: 10/11/2015, 20151606@3 BUD: 12/13/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Pilocarpine (1/16%) Ophthalmic, 15 mL dropper bottle, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653 Lot Code: 20152406@3 BUD: 9/12/2015, 20153108@16 BUD: 11/29/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Prednisolone Sodium Phosphate PF Solution (1%) in 15 mL dropper bottle; For Topical Ophthalmic Use, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653 Lot Code: 20150209@16 BUD: 10/2/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Succinylcholine Chloride (200 mg/10 mL), 10 mL Single Use Syringe (20 mg/mL), For IV use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3292-07 Lot Code: 20152606@4 BUD: 9/23/2015, 20151108@49 BUD: 11/9/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Testosterone cypionate, USP (250 mg/mL), 10 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-2131-07 Lot Code: 20150306@41 BUD: 11/30/2015, 20150505@56 BUD: 11/1/2015, 20150605@21 BUD: 11/2/2015, 20151607@33 BUD: 1/12/2015, 20152104@9 BUD: 10/18/2015, 20152206@24 BUD: 12/19/2015, 20151404@26 BUD: 10/11/2015, 20152104@9 BUD: 10/18/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Testosterone EO-Pro-Cyp 220 (220 mg/mL) 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-2169-06 Lot Code: 20151006@46 BUD: 12/7/2015, 20151607@40 BUD: 1/12/2016, 20152005@32 BUD: 11/16/2015, 20152304@28 BUD: 10/20/2015, 20152304@5 BUD: 10/20/2015, 20152606@2 BUD: 12/22/2015, 20152907@16 BUD: 1/23/2016 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Trace Elements-4 (Zinc Sulfate heptahydrate 4.39 mg, Cupric Sulfate pentahydrate 1.57 mg, Manganese Sulfate monohydrate USP 0.308 mg, Chromic Chloride hexahydrate USP 0.0205 mg), 10 mL Multi-Dose Vial, For IV Injection After Dilution, Dilute Before IV Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3201-07 Lot Code: 20152804@35 BUD: 10/25/2015, 20150505@26 BUD: 11/1/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Triamcinolone acetonide, USP (50 mg/mL), 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3203-07 Lot Code: 20150605@28 BUD: 11/2/2015, 20150607@38 BUD: 1/2/2016, 20150906@3 BUD: 12/6/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Triamcinolone/Lidocaine (40 mg/1%/mL), 10 mL Multidose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3204-07 Lot Code: 20150204@18 BUD: 9/29/2015, 20150906@38 BUD: 12/6/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Triamcinolone diacetate USP (40 mg/mL), 30 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3205-06 Lot: 20150204@7 BUD: 9/29/2015, 20150304@1 BUD: 9/29/2015, 20150604@23 BUD: 10/3/2015, 20150807@50 BUD: 1/4/2016, 20150906@23 BUD: 12/6/2015, 20150906@24 BUD: 12/6/2015, 20152005@42 BUD: 11/16/2015, 20152206@52 BUD: 12/19/2015, 20152406@14 BUD: 12/21/2015, 20152603@26 BUD: 9/22/2015, 20152804@20 BUD: 10/25/2015, 20152904@20 BUD: 10/26/2015, 20152907@8 BUD: 1/25/2016, 20151603@56 BUD: 9/12/2015, 20152406@30 BUD: 12/21/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Triamcinolone diacetate USP PF (40 mg/mL), 2 mL Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3206-01 Lot Code: 20150608@19 BUD: 2/2/2016, 20150807@35 BUD: 1/4/2016, 20152104@12 BUD: 10/1//2015, 20150105@2 BUD: 10/28/2015, 20150605@36 BUD: 11/2/2015, 20150607@26 BUD: 1/2/2016, 20150904@32 BUD: 10/6/2015, 20150906@35 BUD: 12/6/2015, 20151506@45 BUD: 12/12/2015, 20151603@43 BUD: 9/12/2015, 20152204@15 BUD: 10/19/2015, 20152506@35 BUD: 12/22/2015, 20152907@1 BUD: 1/25/2016 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Tri-Mix 30/1/10 (papaverine HCL USP 30 mg/ phentolamine mesylate USP 1 mg/ alprostadil USP 10 mcg/mL), 5 mL Multi-Dose Vial, For Penile Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3256-05 Lot Code: 20151305@17 BUD: 9/16/2015, 20151504@18 BUD: 9/16/2015, 20151903@13 BUD: 9/12/2015, 20151903@13 BUD: 9/12/2015, 20152107@3 BUD: 1/16/2016, 20152204@6 BUD: 9/16/2015, 20152403@13 BUD: 9/12/2015, 20152403@21 BUD: 9/16/2015, 20152904@8 BUD: 9/16/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Tropicamide 0.5%/ Phenylephrine 5%, 2 mL Dropper Bottle For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3298-02 Lot Code: 20151606@11 BUD: 12/13/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Tropicamide 1%/Phenylephrine 2.5% (tropicamide USP 10 mg/ phenylephrine HCL USP 25 mg), 10 mL Ophthalmic Dropper, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3214-07 Lot Code: 20151307@4 BUD: 1/9/2016, 20151805@30 BUD: 11/14/2015, 20152004@23 BUD: 10/17/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Vancomycin Ophthalmic PF 0.5 mL (5 mg/0.5 mL (10 mg/mL), 1 mL syringe, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-0209-64 Lot Code: 20152306@13 BUD: 12/20/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Vitamin D3 in Olive Oil (50,000 IU/mL) 30 mL vial, For IM Use only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3277-06 Lot Code: 20151703@26 BUD: 9/13/2015, 20151703@26 BUD: 9/13/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Voriconazole Solution (1%(10 mg/mL), 15 mL dropper bottle; For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-2815-10 Lot Code: 20150209@40 BUD: 9/16/2015 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Drugs Zinc Sulfate (1 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3226-07 Lot Code: 20150804@1 BUD: 10/5/2015, 20150907@1 BUD: 1/5/2016 Class II Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. US Compounding Inc
Food Fat Boy Fresh Produce - cucumbers. Cucumbers are often referred to as Slicer or American cucumber and are 7-10 inches long ang 1.75 to 2.5 inches in diameter. Sold in cartons containing 24,cucumbers ; 6 cucumbers and 5 lbs of cucumbers. Additionally Super Select Fat Boy Label cucumbers are sold in cartons of 72 and in Reusable Plastic Containers of 65-75 count.. Distributed by Custom Produce Sales, Parlier, CA. Fat Boy lot Codes: 93968, 94506, 94550, 94522, 94513, 93991. Reusable Plastic Containers (RPC) - Super Select label on container. Lot Code: (01) 1 0851821 22000 2 (10) 99 Item # 552678329. Class I Cucumbers received from direct supplier and currently under recall for potential Salmonella contamination were repacked and distributed under a different brand name.. Custom Produce Sales
Food PROVA, Standard Exhausted Vanilla Seeds, Graines VRAC, Caisses-outres of 50 X Lbs, packaged in a cardboard box. Lot # 15-06-07 Class II Potential for the food to contain small pieces of metal. Prova Inc
Food Semi-Sweet Chocolate mini chips packaged in a plastic bad with yellow label and white lettering. UPC: 853522 000306 Lot: 150618 Best By Date: 06/18/2016 Class III Packages of Semi-sweet chocolate mini chips may contain undeclared sunflower seeds, pumpkin seeds, and dried fruit from an Enjoy life foods seed and fruit mix product that was inadvertently added to the Semi-sweet chocolate mini chips product. Enjoy Life Natural Brands
Drugs RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-151-42. Lot #: 14RIF1(A), Expiry: 9/30/2016. Class III Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity. Akorn, Inc.
Biologics Red Blood Cells Leukocytes Reduced W043215055682 Class II Blood product, collected from a donor who disclosed travel history to a malarial endemic area, was distributed. Blood Assurance Inc
Biologics Red Blood Cells Leukocytes Reduced W043215025174 Class II Blood products, collected from a donor who disclosed travel history to a malarial endemic area, were distributed. Blood Assurance Inc
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W043214097313 (double collection) Class II Blood products, collected from a donor who disclosed travel history to a malarial endemic area, were distributed. Blood Assurance Inc
Drugs Acetylcysteine 10% Oph Solution, packaged in a) 6 mL and b) 12 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 2839-081715, Exp 11/17/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs 17-Alpha Hydroxyprogesterone 250 mg/mL in Castor Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 062015, Exp 09/20/2015; 062215, Exp 09/22/2015; 062515, Exp 09/25/2015; and 072115, Exp 10/21/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs 17-Alpha Hydroxyprogesterone 250 mg/mL in Sesame Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 060815, Exp 09/08/2015; 062915, Exp 09/29/2015; 072315, Exp 10/23/2015; and 760-081815, Exp 11/18/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs BIMIX INJ 30 mg-1 mg/mL Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 071015, Exp 09/10/2015; 072115, Exp 09/21/2015; and 080715, Exp 10/07/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs Cyclosporin 0.1% Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 062915, Exp 09/29/2015; 070915, Exp 10/09/2015; 073015, Exp 10/30/2015; 080315, Exp 11/03/2015; and 080615, Exp 11/06/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs Dexamethasone 0.4% Opth Ointment, 3.5 g ointment tubes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 062515, Exp 09/25/2015; and 070615, Exp 10/06/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs DUAL TEST CYP/ENA 1:1 200 mg/mL Injection, packaged in a) 5 mL and b) 100 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 060815, Exp 09/08/2015; 061615, Exp 09/16/2015; 062915, Exp 09/29/2015; 070615, Exp 10/06/2015; 071615, Exp 10/16/2015; 073015, Exp 10/30/2015; and 080615, Exp 11/08/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs Glycerin Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 071515, Exp 10/15/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs HCG 1000 Units/mL SUB-Q Injection, packaged in a)1.5 mL, b) 2 mL, c) 2.4 mL, d) 4 mL, e) 6 mL, f) 7.5 mL, g) 8 mL, and h) 9 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 080415, Exp 09/04/2015; 080515, Exp 09/05/2015; 080615, Exp 09/06/2015; 080715, Exp 09/07/2015; 081015, Exp 09/10/2015; 081115, Exp 09/11/2015; 081215, Exp 09/12/2015; 081315, Exp 09/13/2015; 081415, Exp 09/14/2015; 1702-081715, Exp 09/17/2015; 1702-081815, Exp 09/18/2015; and 1702-081915, Exp 09/19/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs HCG 1000 U/ LIDO 0.2%/mL Injection, packaged in a) 3 mL and b) 8 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 080415, Exp 09/04/2015; and 4721-081715, Exp 09/17/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs HCG 2000 Units/mL Injection, packaged in a) 4 mL and b) 15 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 080415, Exp 09/04/2015; and 080715, Exp 09/07/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs HCG 3000 Units/mL Injection, 2 mL vial, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 081015, Exp 09/10/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs HCG 5000 Units/mL Injection, 0.4 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 081315, Exp 09/13/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs HCG 10,000 Units/mL Injection, packaged in a) 1 mL, b) 1.2 mL, c) 1.6 mL, d) 2.0 mL, e) 2.4 mL, f) 3.6 mL, g) 4 mL, h) 4.8 mL vials; and i) 0.1 mL, j) 0. 2 mL, k) 0.3 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 080615, Exp 09/06/2015; 081215, Exp 09/12/2015; 081315, Exp 09/13/2015; 081415, Exp 09/14/2015; 1730-081715, Exp 09/17/2015; 1730-081815, Exp 09/18/2015; and 1730-081915, Exp 09/19/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs LIPO B Injection, packaged in a) 2 mL, b) 12 mL, c) 15 mL, or d) 30 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 061215, Exp 09/12/2015; 061915, Exp 09/19/2015; 070115, Exp 10/01/2015; 072315, Exp 10/23/2015; and 073115, Exp 10/31/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs LIPO-B Special Injection,12 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 073115, Exp 10/31/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs Methylcobalamin 1 mg/mL (Pres Free) Injection, 1 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 072915, Exp 09/13/2015; 080415, Exp 09/19/2015; and 1345-081815, Exp 10/03/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs Methylcobalamin 5000 mcg/mL Preservative Free Injection, packaged in a) 4 mL and b) 8 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 072715, Exp 09/10/2015; and 073015, Exp 09/13/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs Methylcobalamin 20 mg/mL PF Injection, 0.05 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 3327-081715, Exp 09/17/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs Methylcobalamin 25 mg/mL PF Injection, 0.5 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 072915, Exp 09/13/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs Methylcobalamin 30 mg/mL PF Injection, 0.1 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 072815, Exp 09/10/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs MIC Injection, 30 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 071315, Exp 10/13/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs Progesterone 100 mg/mL IM* Injection in Sesame Oil, 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 062315, Exp 09/23/2015; 071615, Exp 10/16/2015; and 080615, Exp 11/06/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs Progesterone 100 mg/mL in Corn Oil Injection, 2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 072915, Exp 10/29/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs Progesterone 100 mg/mL Ethyl Oleate Injection, 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 072415, Exp 10/24/2015; and 080715, Exp 11/07/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs QUAD MIX (30 mg-1 mg-20 mcg-0.16 mg / mL) Injection, 5.2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 071315, Exp 09/13/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs Sermorelin 9 mg/10 mL SUB-Q* Injection, packaged in a) 3 mL, b) 5 mL, c) 6 mL, or d) 9 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 080515, Exp 09/05/2015; 080715, Exp 09/07/2015; 081115, Exp 09/11/2015; and 081415, Exp. Date 09/14/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs Sermorelin 1000 mcg/mL SUB-Q* Injection, packaged in a) 3 mL, b) 6mL, c) 7.5ml, d) 9 mL or e) 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 080415, Exp 09/04/2015; 080515, Exp 09/05/2015; 080615, Exp 09/06/2015; 080715, Exp 09/07/2015; 081015, Exp 09/10/2015; 081115, Exp 09/11/2015; 081215, Exp 09/12/2015; 081315, Exp 09/13/2015; 081415, Exp 09/13/2015; 081515, Exp 09/15/2015; 453-081715, Exp 09/17/2015; 453-081815, Exp 09/18/2015; and 453-081915, Exp 09/19/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs sermorelin 1000 mcg/mL / LIDO 0.2% Injection, 6 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 080415, Exp 09/04/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs Testosterone Cypionate 50 mg/mL Injection, 1 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 081215, Exp 11/12/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs Testosterone Cypionate 200 mcg/mL in Sesame Oil Injection, packaged a) 5 mL and b) 100 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 060815, Exp 09/08/2015; 061615, Exp 09/16/2015; 070615, Exp 10/06/2015; 071615, Exp 10/16/2015; and 080615, Exp 11/06/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs Testosterone Cypionate 200 mcg/mL in Corn Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 070115, Exp 10/01/2015; and 071015, Exp 10/10/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs Testosterone CYP/ENAN/PROP Injection, 66.6 mg/66.6. mg/66.6 mg/mL, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 062915, Exp 09/29/2015; and 071615, Exp 10/16/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs Testosterone CYP/ENAN/PROP Injection in Cottonseed Oil, 66.6 mg/66.6. mg/66.6 mg/mL, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 060415, Exp 09/04/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs TRIMIX #1 Injection, 4.2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 071015, Exp 09/10/2015; 071715, Exp 09/17/2015; and 073015, Exp 09/30/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs TRIMIX #2 (24 mg-0.8 mg-20 mcg /mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot # 070815, Exp 09/08/2015; 071715, Exp 09/17/2015; 073115, Exp 10/012015; 080415, Exp 10/04/2015; and 080615, Exp 10/06/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs TRIMIX #3 (24 mg-1 mg-20 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 070915, Exp 09/09/2015; and 080315, Exp 10/03/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs TRIMIX #4 (27 mg-1.5 mg-50 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 070715, Exp 09/07/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Drugs TRIMIX SPECIAL (30 mg-1 mg-10 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. Lot #: 073115, Exp 10/01/2015 Class II Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Devices HARMONIC ACE®+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. 91V2X, Exp Date, 2019-06; Batch #, L91V62, Exp Date, 2019-06; Batch #, L91W1T, Exp  ...
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Class II The firm decided to recall the product due to receiving complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging. Ethicon Endo-Surgery Inc
Biologics Red Blood Cells Leukocytes Reduced W202214079013 Class II Misbranded red blood cell was distributed. American National Red Cross, Penn Jersey Region
Biologics Red Blood Cells Leukocytes Reduced W041115027768L Class II Blood products, collected from donors who resided in or traveled to an area considered endemic for malaria, were distributed. Blood Systems, Inc. dba United Blood Services Texas
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated W041114084004J Class II Blood products, collected from donors who resided in or traveled to an area considered endemic for malaria, were distributed. Blood Systems, Inc. dba United Blood Services Texas
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W041115024436Z (double collection); W041115024240M (double collection); W041115021918A (double collection); W041114084004J Class II Blood products, collected from donors who resided in or traveled to an area considered endemic for malaria, were distributed. Blood Systems, Inc. dba United Blood Services Texas
Biologics Red Blood Cells, Leukocytes Reduced, Irradiated W066515500010 Class II Blood products, which were not filtered according to specifications, were distributed. Blood Bank of Alaska, Inc.
Biologics Red Blood Cells, Leukocytes Reduced W066515651621; W066515422950; W066515421699; W066515500056; W066515270060; W066515600269; W066515420078; W066515670008; W066515670027; W066514602548; W066514601694; W066514601696; W066514702184; W066514428278; W066514653673; W066514671289; W066514671292; W066514601547; W066514601566; Class II Blood products, which were not filtered according to specifications, were distributed. Blood Bank of Alaska, Inc.
Drugs Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), 10 mL bottles, Rx Only, Hi-Tech Pharmacal, Amityville, NY 11701, Made in USA, NDC # 50383-901-10 Lot # 346191, Exp. 12/2016 Class III Defective Container: Product missing safety seal around the neck of the bottle. The product label indicates, "Tamper Evident: Do not use if printed seal around cap is broken or missing." Because the product is missing the approved component and is not consistent with the labeling, the lot is being recalled. Akorn, Inc.
Biologics Apheresis Red Blood Cells, Leukocytes Reduced W202715255607 (double collection); W202715255616 (double collection); W202715252819 (double collection) Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American Red Cross Greater Alleghenies Region
Biologics Red Blood Cells, Leukocytes Reduced W202715252739; W202715255615; W202715252727; W202715252732; W202715255619; W202715252761; W202715252714; W202715252745; W202715252713; W202715252717; W202715252777; W202715252780; W202715252781; W202715250301; W202715250312; W202715250318; W202715252767; W202715252769; W202715252774; W202715252768; W202715252770; W202715252773; W202715252775; W202715255600; W202715255605; W202715255609; W202715252778; W202715255610; W202715252765; W202715250298; W202715250310; W202715250317; W202715252721 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American Red Cross Greater Alleghenies Region
Biologics Red Blood Cells, Leukocytes Reduced, Irradiated W202715252766 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American Red Cross Greater Alleghenies Region
Biologics Plasma Frozen within 24 hours (FP24) W202715255615; W202715252752; W202715252732; W202715252780; W202715250295; W202715250301; W202715252772; W202715255601; W202715255610; W202715255609; W202715252757; W202715252766 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American Red Cross Greater Alleghenies Region
Food HUA ZHI YING GOURD CANDY, 250G(8.8oz), each carton is packed with 40/250G units, An Shun Trading Co., LTD 4425B 1st AVE BROOKLYN, NY 11232 (718) 509-9558 none Class I The product was found to contain undeclared sulfites and FD&C Blue # 1 based on sampling and analysis by New York State Department of Agriculture and Markets. A & S Food Trading Inc.
Food Baked Brie Herb/Garlic. An 8 ounce portion of Baked Brie wrapped in Phyllo Dough with garlic and herbs. Product shipped frozen, but sold thawed in a cheese case. UPC 2 17563 01499 7 SELL BY or BEST BY dates: 10/1/15 and up to 10/21/15 Class I Baked Brie Herb/Garlic was recalled due to undeclared pecans. Market of Choice Inc.
Devices CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers. M367350, M370110, M375100, M381740, M406940, M407750, M413300, M413310, M434210, M436400, M445180, M647110, M093610, M113720, M122370, M153900, M206940, M250330, M250340, M258890, M315660, M333490, M340650, M340660, M418340, M421310, M450400, M465510, M473820, M499620, M519670, M519870, M535840, M560410, M569020, M665970, M085160, M096150, M107000, M130450, M155430, M163490, M203230, M215600, M237160, M280540, M295050, M309920, M315640, M335660,  ...
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Class II Sterility of the product cannot be assured. Civco Medical Instruments Co. Inc.
Devices CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 674-030, 674-030-T, 674-031, 674-031-T, 674-035, 674-036, 674-044, 674-052, 674-059, 674-061. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers. M099850, M102860, M109690, M116920, M121840, M145200, M167240, M177420, M183850, M187880, M197330, M198000, M214900, M223090, M243020, M259940, M275080, M299890, M307610, M323480, M324340, M336880, M371260, M388610, M418830, M468260, M505290, M508000, M595790, M610020, M614660, M619370, M328280, M347150, M354390, M359630, M385190, M397110, M402790, M444170, M473920, M477540, M492030, M499400, M507160, M513450, M525040, M541820, M643750, M030030,  ...
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Class II Sterility of the product cannot be assured. Civco Medical Instruments Co. Inc.
Devices CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 10787043, 11001906, 11001906(CMI), 613-247, 613-247(CMI), 620-116, 639-014, 639-016, 639-021, 639-024, 639-025, 639-026, 639-027, 639-033, 639-035, 639-047, 639-051, 658-001, 667-106, 667-106(CMI), 667-127, 672-001, 698-007, 698-009, 698-013, 698-015, 742-397-T, 742-416, and H48392LT. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers. M475840, M475850, M483080, M184760, M201120, M201220, M201230, M229890, M230450, M248410, M265470, M282270, M307490, M322230, M367370, M370090, M381360, M421260, M431550, M452150, M458370, M488300, M514070, M572510, M576810, M606320, M626250, M639290, M642350, M648020, M540640, M543800, M551990, M592190, M604120, M448100, M477600, M477700, M504340, M504350, M507520, M524270, M544100, M569330, M569340, M590710, M600460, M632390, M643140, M604180,  ...
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Class II Sterility of the product cannot be assured. Civco Medical Instruments Co. Inc.
Devices CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REF 667-132. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers. M093630, M093640, M093650, M128890, M128930, M163120, M191470, M191880, M202970, M205490, M211000, M218540, M218550, M218560, M240080, M250210, M262470, M308100, M328800, M333890, M371670, M384130, M396710, M399210, M399320, M399340, M403640, M412450, M421190, M423310, M424480, M451230, M457640, M461290, M468590, M470900, M473810, M487020, M511040, M545900, M545910, M547320, M560870, M570280, M570290, M585600, M585610, M586670, M594480, M600470,  ...
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Class II Sterility of the product cannot be assured. Civco Medical Instruments Co. Inc.
Devices CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers. M116270, M119900, M121920, M125640, M130290, M170900, M185950, M204790, M211280, M215550, M235410, M240880, M252870, M303130, M320620, M320660, M346050, M368820, M379870, M391260, M395270, M418200, M476020, M497220, M508200, M594740, M598320, and M624430 Class II Sterility of the product cannot be assured. Civco Medical Instruments Co. Inc.
Devices Cyberonics Vagus Nerve Stimulation (VNS) Therapy AspireSR Generator, Model 106 Serial Numbers: 37719, 37899, 38123, 38414, 38428, 39385, 39531, 39607, 39801, 39821, 40037, 40048, 40249, 40251, 40271, 40354, 40428, 40488, 40526, 40603, 40751, 41000, 41109, 41152, 41805, 42022, 42780 Class II Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit potential for decreased battery longevity. Cyberonics, Inc
Food Ocean's Halo, The Seaweed Chip. Sea Salt Flavor; 2.5 oz. bag Organic and Gluten Free ingredients. USDA Organic. Outer Case UPC: 10851899005174 Unit (Bag) UPC: 8 51899 00517 7 Distributed by New Frontier Foods, Inc. Burlingame, CA. Lot numbers: 082416, 091416, 091516, 091616 Class II Routine tests showed levels of gluten above the FDA limit for a gluten free product. New Frontier Foods/Ocean's Halo
Food Ocean's Halo, The Seaweed Chip. Chili Lime Flavor; 2.5 oz. bag Organic and Gluten Free ingredients. USDA Organic. Outer Case UPC: 10851899005198 Unit (Bag) UPC: 8 51899 00519 1 Distributed by New Frontier Foods, Inc. Burlingame, CA. Lot number: 091716 Class II Routine tests showed levels of gluten above the FDA limit for a gluten free product. New Frontier Foods/Ocean's Halo
Food Ocean's Halo, The Seaweed Chip. Korean BBQ Flavor; 2.5 oz. bag Organic and Gluten Free ingredients. USDA Organic. Outer Case UPC: 10851899005181 Unit (Bag) UPC: 8 51899 00518 4 Distributed by New Frontier Foods, Inc. Burlingame, CA. Lot numbers: 082416, 091516, 091616, 092116 Class II Routine tests showed levels of gluten above the FDA limit for a gluten free product. New Frontier Foods/Ocean's Halo
Biologics Red Blood Cells, Leukocytes Reduced W205315206508; W205315214173 Class II Misbranded red blood cells were distributed. American Natl. Red Cross-Greater Chesapeake & Potomac Region
Drugs HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 3000 count bottles, Rx only, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL 35811, NDC: 0603-3855-93. T084M14A, T085M14A, T086M14A; Exp 12/16 Class II Presence of Particulate Matter. Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
Food Florida Avocado, 14 count cardboard boxes. Invoice #5781, Sale P.O. #29899.438426.74307, Shipped Date 08/18/15 Invoice #5781, Sale P.O. #29899.438426.74307, Shipped Date 08/18/15 Class I Avocados positive for Salmonella Tropical Produce Specialist Corp
Food Dole All Natural SPINACH; Net Wt. 8 oz. (227 g). Enjoy by 10-15-15, UPC 7143000976 Product of the USA Excellent Source of Vitamin A, K, C, Folate and Manganese Distributed by Dole Fresh Vegetables, Monterey, CA Lot code A27409B and A27409A, Enjoy by October 15, 2015. Class I Random Sampling by the Michigan Department of Agriculture had a positive result for Salmonella in one bag of spinach. Dole Fresh Vegetables Inc
Devices IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic information (Patient Name, Patient Medical Record Number and/or Accession Number in previously signed reports that have since changed. Model # L9M2100 Class II Customers have experienced IMPAX CV software, specifically, Demographics Manager (DM), not producing correct pdf reports after the reports, at the time of physician signature, were correct. AGFA Healthcare Corp.
Devices Taut Introducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity. Lot Numbers - 73A1500175, 73A1500306, 73B1500116, 73B1500418 Class II The defective component can cause gas leakage through the device. This can result in loss of pneumoperitoneum, potentially necessitating removal of the defective device and insertion of another device. Teleflex Medical
Food Fresco Fresh Banana Strawberry Yogurt Parfait Net Wt. 6.5 oz. packaged in clear plastic tub. Lot Numbers: 10276101, 10279101, 10283101, 10278101, 10280101, 10282101, 10285101; UPC: 7-17524-77501-6 and 7-17524-77512-2 Class I May contain undeclared almonds. Del Monte Fresh Produce N.A.
Food Fresco Fresh Strawberry Yogurt Parfait Net Wt. 6.5 oz. packaged in clear plastic tub. Lot Numbers: 10278101, 10280101; UPC: 7-17524-77503-0 Class I May contain undeclared almonds. Del Monte Fresh Produce N.A.
Food Fresco Fresh Strawberry Blueberry Yogurt Parfait Net Wt. 6.5 oz. packaged in clear plastic tub. Lot Numbers: 10276101, 10279101, 10280101, 10283101, 10282101 Class I May contain undeclared almonds. Del Monte Fresh Produce N.A.
Devices Hill-Rom 100 Low Bed (GPAC) AC Powered adjustable hospital bed Product # P3930A; Dates of Manufacture 5-DEC-2007 to 14-SEP-2015; Serial numbers from I325AR0038 thru Q257AR2299 Class II Hill-Rom is voluntarily recalling the Hill-Rom 100 Low Bed due to complaints of patient injury when exiting the beds set at the lowest position setting. Hill-Rom, Inc.
Devices Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. In vitro diagnostic machine component. During transport from the Bulk Loader Module (BLM), catalog number 07135645001, to the cobas p 512/p 612 pre-analytical instruments, sample tubes may inadvertently open and spill, causing contamination of the system. Class II Roche issued a voluntary recall for a single unit of the Bulk Loader Module for cobas p 512/612, due to the design of the loader making it possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples during processing. Roche Diagnostics Operations, Inc.
Biologics Plasma Frozen within 24 hours (FP24) W20171535649700L, W20171536396200J, W201715363983009, W201715377523006, W20171537757000T, W20171537757700F, W20171537760000C, W201715377603006, W20171538171500H, W20171538985100L, W20171538987900Y, W20171538988000B, W201715392821002, W20171539402800K, W20171539406400C, W201715394076004, W20171539407900Z, W201715394084004, W201715397160001, W20171539727000Q, W20171539742100S, W20171540069700C, W20171540254400E, W20171541503000N Class II Blood products, collected from inelieible donors, were distributed. American National Red Cross (The)
Biologics Red Blood Cells, Leukocytes Reduced W20171538481500Z, W20171538481700V, W20171538483600P, W20171538484800H, W20171538485400L, W201715389618002, W201715389625004, W201715389723000, W20171538973200Z, W20171538973400V, W20171538973800N, W20171538974700L, W20171538985100L, W20171538987900Y, W201715389890007, W201715389891005, W20171539105100X, W20171539246000K, W201715392468004, W20171539564900K, W20171539567600E, W20171539568200I, W201715395700009, W201715395710005, W20171539572900K, W20171539574400M, W20171539575500G, W20171539576600A, W201715395768006, W201715396479008, W20171539648600A, W201715396488006, W201715396500009, W201715397127003, W20171539718300O, W20171539720300B, W201715397215003, W20171539723300*, W20171539726400M, W20171539727000Q, W20171539740900K, W20171539741600M, W20171539741900G, W20171539742100S, W20171539742400M, W20171539743100O, W20171540050400P, W20171540050800H, W20171540070000H, W20171540092400M,  ...
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Class II Blood products, collected from inelieible donors, were distributed. American National Red Cross (The)
Biologics Cyroprecipitated AHF W20171540714900U Class II Blood products, collected from inelieible donors, were distributed. American National Red Cross (The)
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W20171538483400T, W20171538483400T, W20171538483800L, W201715389619000, W201715389619000, W201715389849009, W201715389881009, W201715389881009, W20171539725600M, W20171539725600M, W20171540091600M, W20171540091600M, W20171540091800I, W20171540091800I, W201715406496008, W20171540716500U, W20171540716500U, W20171540717900I, W20171540717900I, W20171540924800T, W20171540924800T, W201715410582002, W201715410582002, W20171541500800J, W20171541500800J, W20171541502200N, W20171541502200N Class II Blood products, collected from inelieible donors, were distributed. American National Red Cross (The)
Biologics Cryoprecipitated AHF, Pooled W20171591814700, W20171591833900K, W20171591834200U, W20171591835700G, W20171591836500G, W20171591840800Q Class II Blood products, collected from inelieible donors, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced Irradiated W201715384812004, W201715389632006, W20171539566300O, W20171539572100, W20171539722900S, Class II Blood products, collected from inelieible donors, were distributed. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing W201715363979001, W20171536398000F, W201715363983009, W20171536997900G, W20171536997900G, W20171536998500K, W20171536999400I, W20171537752900V, W20171537753900R, W20171537754700R, W20171537755900J, W20171537756500N, W20171537757500J, W20171537757600H, W201715378564009, W20171537857000D, W20171537859700S, W20171538168800S, W20171538169700Q, W20171538169800O, W20171538170400N, W20171538960500C, W201715389618002, W201715389625004, W201715389632006, W201715389723000, W20171538973200Z, W20171538973300X, W20171538973400V, W20171538973800N, W20171538974600N, W20171538974700L, W201715389890007, W201715389891005, W20171539105100X, W20171539200200Z, W20171539200400V, W20171539200700P, W20171539200800N, W20171539246000K, W201715392468004, W20171539276400P, W20171539276500N, W20171539276600L, W20171539276700J, W20171539277100R, W20171539277200P, W20171539277200P, W20171539277300N, W20171539277500J,  ...
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Class III Blood products, collected from inelieible donors, were distributed. American National Red Cross (The)
Food Classic Baklava; Net WT 5.5 lbs (2.43 kg) total weight of five trays bundled together. 38-68 pieces per tray Item number 11930 Manufactured by Kronos Foods Corporation, Madera, CA Item number 11930 Lot Number 15264, Exp 3/21/2016; lot number 152271, Exp 3/28/16; lot number 15265, Exp date 3/22/2016 Class II Potential for metal fragments in baked goods - discovery after increased Metal Detector Rejections. Kronos Foods, Inc.
Food Natural Mini Caterer's Assortment Net WT 4 lbs. (1.81 kg) total weight of five trays bundled together. 38-68 pieces per tray Item number 10169 Manufactured by Kronos Foods Corporation, Madera, CA Item number 10169 Lot Number 15271, Exp 12/28/15; Lot Number 15273, Exp 12/30/15; Lot Number 15265, Exp 12/22/15; Lot Number 15259, Exp 12.16/15. Class II Potential for metal fragments in baked goods - discovery after increased Metal Detector Rejections. Kronos Foods, Inc.
Food Deluxe Assortment, Net WT 5 lbs. (2.27 kg) total weight of five trays bundled together. 38-68 pieces per tray Item number 10922 Manufactured by Kronos Foods Corporation, Madera, CA Item number 10922 Lot Number 15267, Exp 3/24/16 Class II Potential for metal fragments in baked goods - discovery after increased Metal Detector Rejections. Kronos Foods, Inc.
Food Chocolate Almond Treasure Net WT 4 lbs. (1.81 kg) total weight of five trays bundled together. 38-68 pieces per tray Item number 10932 Manufactured by Kronos Foods Corporation, Madera, CA Item number 10932 Lot Number 15272, Exp 3/2916; Lot Number 15258, Exp 3/15/16; Lot Number 15260, Exp 3/17/16. Class II Potential for metal fragments in baked goods - discovery after increased Metal Detector Rejections. Kronos Foods, Inc.
Food Baklava Sample Assortment Net WT 4 lbs. (1.82 kg) total weight of five trays bundled together. 38-68 pieces per tray Item number 10944 Manufactured by Kronos Foods Corporation, Madera, CA Item number 10944 Lot Number 19275, Exp 4/02/16; Lot Number 15266, Exp 3/23/16; Class II Potential for metal fragments in baked goods - discovery after increased Metal Detector Rejections. Kronos Foods, Inc.
Food Sample Assortment Net WT 4 lbs. (1.82 kg) total weight of five trays bundled together. 38-68 pieces per tray Item number 11904 Manufactured by Kronos Foods Corporation, Madera, CA Item number 11904 Lot Number 15268, Exp 3/25/16. Class II Potential for metal fragments in baked goods - discovery after increased Metal Detector Rejections. Kronos Foods, Inc.
Food Baklava Assortment Net WT 4 lbs. (1.82 kg) total weight of five trays bundled together. 38-68 pieces per tray Item number 11604 Manufactured by Kronos Foods Corporation, Madera, CA Item number 11604 Lot Number 15271, Exp 3/2816. Class II Potential for metal fragments in baked goods - discovery after increased Metal Detector Rejections. Kronos Foods, Inc.
Food Orange Blossom Baklava Net WT 5.5 lbs. (249 kg) total weight of five trays bundled together. 38-68 pieces per tray Item number 11934 Manufactured by Kronos Foods Corporation, Madera, CA Item number 11934 Lot Number 15258, Exp 3/15/16. Class II Potential for metal fragments in baked goods - discovery after increased Metal Detector Rejections. Kronos Foods, Inc.
Food Martinelli's Gold Medal Sparkling Cider, 8.4 oz glass bottles; Packed in 12 pack, UPC 0 41244 00256; item number 12256; 4/6 packs, Tray UPC 0 41244-99932 3, item number 46256; 6 pack Retail UPC 0 41244 46256 8. Single 8.4 oz. bottle, UPC 041244 00256 6 12 pack:Best Before dates include 03/05/2018 to 04/11/2018. 6 pack Best Befroe dates include 3/02/2018 to 04/15/2018. Class II Potential for glass fragments in 8.4 oz. bottles of four varieties of sparkling cider. S. Martinelli & Co
Food Martinelli's Sparkling Red Grape, 8.4 oz glass bottles (250 mL); Packed in 12 pack, UPC 0 41244 99926 2; item number 99926; 4/6 packs, Tray UPC 0 41244-64926 6, item number 64926 6 pack retail UPC 0 41244-64026 3. Single 8.4 oz. bottle - UPC 0 41244 99026 9. 12 pack: Best Before dates include 05.28/18 to 09/04/2018. 6 pack Best Before dates include 08/31/18 to 09/11/2018. Class II Potential for glass fragments in 8.4 oz. bottles of four varieties of sparkling cider. S. Martinelli & Co
Food Martinelli's Sparkling White Grape, 8.4 oz glass bottles (250 mL); Packed in 12 pack, UPC 0 41244 99925 5; item number 99925; Single 8.4 oz. bottle - UPC 0 41244 99025 2. 12 pack: Best Before dates include 05/07/18 to 05/09/2018. Class II Potential for glass fragments in 8.4 oz. bottles of four varieties of sparkling cider. S. Martinelli & Co
Food Martinelli's Sparkling Northwest Blend Cider , 8.4 oz glass bottles (250 mL); Packed in 12 pack, UPC 0 41244 99057 5; item number 99957; Single 8.4 oz. bottle - UPC 0 41244 99057 3. 12 pack: Best Before dates include 03/20/2018 to 05/15/2018 Class II Potential for glass fragments in 8.4 oz. bottles of four varieties of sparkling cider. S. Martinelli & Co
Devices Easy Dial Oxygen Regulator, 168708D and 168715D. Eight liter from .0.25 to 8 liters, 15 liter from 0.5 liter to 15 liters of oxygen per minute. Lot numbers 072215 and 072315. Class II It has come to our attention that the above lots of Oxygen Dial Regulators, could have the settings label off by one position. This means that when the indicator arrow points to OFF position, the regulator is actually on the half liter setting (0.50), for the 15 liter. The 8 liter, instead of being in the OFF position, the regulator will be in the quarter liter setting (0.25). Precision Medical, Inc.
Devices SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870-07. Product Usage: SilverStat is an effective barrier to microbial penetration for moderate to heavy exudating partial and full-thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor and graft sites, traumatic and surgical wounds and 1st and 2nd degree bums. SilverStat is indicated for external use only. Lot Numbers: 2012-0809; 2012-0903; 2012-1011. Class II During a review of the IFU of the SilverStat Pads, it was found that the IFU did not match that submitted in the original 510k TZ Medical Inc.
Devices Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03 Lot Numbers: AGR554; AGR554\20; AGR554\24; AGR554/24; AGR570\28; AGR570/43; AGR744124; AGR744137. Class II The IFU of the Neptune Plus Pads, does not match that submitted in the original 510k. Need to remove: for haemostasis following needle/sheath removal TZ Medical Inc.
Biologics Red Blood Cells, Leukocytes Reduced, Irradiated W035415024251 Class II Blood product, for which the donor was previously deferred due to malarial history, was distributed. Community Blood Center
Drugs L-Glutamine Injectable, 30mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs L-Tyrosine Injectable, 25mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs L-Tryptophan Injectable, 30mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs EDTA Disodium Injectable, 150mg/mL, 100mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs Acetyl-L-Carnitine Injectable, 100mg/mL, 30mL vial, L-Carnitine Injection 500mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs Ascorbic Acid Injectable 500mg/mL, packaged in a) 10mL vials, b) 50mL vials, c)100mL vials, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs MICML TRNDPPC Injection (Preserved) 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs Riboflavin-5-Phosphate Injectable,10mg/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs Procaine Injectables 20mg/mL and 2%, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs Co-Enzyme Q-10 Injectable, 20mg/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs Vitamin D3 Injectable, 10,000 U/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs Methylcobalamin Buffered Injectable, 1mg/mL, packaged in a) 10mL vial, b) 30mL Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs Taurine Injectable, 50mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs Magnesium Sulfate 50% Injectable, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs Cyanocobalamin Buffered Injectable 3mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs Glucosamine HCL Injectable, 200mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 10/4.75%; Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 5/2.5%; Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 5/4.2%, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs Methylcobalamin Buffered Injectable, 5mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs HCG (Lyophilized) Injectable, 5000 units/vial, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs Chromium Injectable, 200mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs EDTA Calcium Disodium Injectable, 300mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs TNPRDC Injection, 6 mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs DMPS Injectable, 50mg/mL, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs Magnesium Sulfate Injectable, 14.28%, 7mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs Green Tea (EGCG) Injectable, 10mg/mL,10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs TNPDR Injection Buffered, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs Calcium Gluconate (680mOsm/L) Injection 10%, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs Sermorelin/GHRP-6/GHRP-2 Injection 3MG/3MG/3MG, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs Hydroxocobalamin Injection (Buffered) 1mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs B12 Injection 12.5/12.5MG, 3mL, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs Magnesium Chloride Hexahydrate Injection 200mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs L-Arginine Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs DMSO 99% Injection, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs L-Glutathione Injection, 200mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs Folic Acid Injection, 10mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs Piracetam Injection, 200mg/mL,10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs Pyridoxine Injection, 100 mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs DMAE Dimethylaminoethanol Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs Dexpanthenol Injection, 250mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs M.I.C Injection (Preserved), 25/50/25mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs Zinc Sulfate (Elemental) Injection, 10mg/mL, 30 mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs Thiamine HCl Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs Testosterone Cypionate Injection (Sesame Oil), 200mg/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs Potassium Chloride Injection (20mEq/10mL), 2mEq/ML, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs Magnesium Sulfate Injection (4060mOsm/L), 50%, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs Thiotic Acid Injection, 25mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs MIC w/Methyl B-12 Preserved Injection, 25/50/50/1mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Drugs Methylcobalamin Injection Buffered 5mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 All lots Class II Lack of Assurance of Sterility Downing Labs, LLC
Devices Synthes Application Instrument for Sternal ZIPFIX. Indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion. Synthes Application Instrument for Sternal ZIPFIX, Part Number 03.501.080. Lot Numbers 3783913, 7516728, 7606881, 7659168, 7666085, 7671934, 7689244, 7694377, 7720599, 7738572, 7738573, 7740498, 7767497, 7803768, 7806881, 7818677, 7818682, 7821672, 7827088, 7831855, 7833606, 8068078, 8130898, 8145793, 8207769, and 8215969. Class II Certain lots of the Application Instrument for Sternal ZIPFIX that were previously recalled on August 19, 2015 and subsequently repaired and returned to customers between August 26, 2015 and September 23, 2015. The screws on the repaired instruments have the potential to break or loosen. DePuy Synthes is requesting the return of the repaired device in exchange for a new device. Synthes (USA) Products LLC
Devices 1 Step 12 Panel Cup, Item No. NBCA-12M-W These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. 144408 150675 Class II Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Ameditech Inc
Devices 10-Panel Pipette Drug Screen, Item No. PSP-10M These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. 133930 143597 Class II Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Ameditech Inc
Devices 11 Panel Cup (OPI2000) w/Adult, Item No. 71125AA2K ; and 11 Panel Cup (OPI300) w/Adult, Item No. 71125AA These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. 150503 144376 Class II Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Ameditech Inc
Devices 11 Panel Dip Card (OPI 2000), Item No. 11125AA2K; 11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. 142898 151145 142899 Class II Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Ameditech Inc
Devices 12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. 144302 150323 150661 151143 151467 Class II Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Ameditech Inc
Devices ArcPoint Labs 10 Panel Dip Screen (OXY), Item No. APD-10MO These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. 141001 Class II Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Ameditech Inc
Devices CLIA RDTC 12-Panel Cup and CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. 142320 143666 143753 144217 144414 144439 144454 144510 144952 Class II Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Ameditech Inc
Devices DrugCheck Pipette 10 Drug Test, Item No. 41025 DC These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. 142512 Class II Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Ameditech Inc
Devices DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. 144216 150546 150746 Class II Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Ameditech Inc
Devices DrugSmart 10 Test Cup (PCP & MDMA), Item No. 61055D; DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. 142293 151047 151233 Class II Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Ameditech Inc
Devices DrugSmart 11 Test Cup, Item No. 61127D; DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D; DrugSmart 9 Test Cup (BUP), Item No. 60960D; DrugSmart Cup 10, Item No. 61093D-3C These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. 140770 142294 151050 151527 142527 140998 142526 150596 151122 151196 Class II Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Ameditech Inc
Devices DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D; DrugSmart Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520D These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. 141379 144260 150225 Class II Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Ameditech Inc
Devices EDI BZO UNCUT SHEET-CARD, Item No. 100170 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. 134268 134898 140206 140218 140453 140551 141053 141129 143471 143553 144468 144557 150317 150531 150606 150638 150834 151154 152021 152104 134067 134504 140495 141010 141128 141197 143716 143784 143866 144003 144042 144199 144270 144332 144443 144502 144555 150237 150347 150440 150901 150989 151239 151925 151984 152003 152103 Class II Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Ameditech Inc
Devices iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142; iCup DX 11 Panel w/Adulterant, Item No. I-DXA-1117-131; iCup DX 12 Panel w/Adulterant, Item No. I-DXA-1127-023; iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013; iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016; iCup DX Drug Screen, Item No. I-DXA-1127-023 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.     141210 141425 141561 141870 141994 142126 143608 144152 144218 145067 150105 150167 151215 150976 141844 141929 142258 142314 143606 144511 145058 145059 150549 150867 150919 150920 151179 151190 151255 151338 151476 144377 150101 150285 150420 151161 151399 151696 144209 144463 150018 150107 150690 150883 141492 141519 141552 141726 Class II Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Ameditech Inc
Devices Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5; Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP; Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-12BUP; Immutest 5 panel, Item No. IMCA-5AB-W; Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W; Immutest 7 panel, Item No. IMCA-7P; ImmuTest Cup 7-panel w/ Adulteration, Item No. IMCA-7P These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.     144380 144564 150505 150908 151538 142098 144103 150313 150909 141645 144563 150483 151337 142076 142966 144263 151540 Class II Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Ameditech Inc
Devices Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.     G140435 G140436 G150005 G150016 G150030 G150083 G150125 Class II Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Ameditech Inc
Devices Premier Clia Waived 12 panel Tilt Cup, Item No. C12APC These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.     141748 Class II Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Ameditech Inc
Devices ProScreen 10 Drug Panel Cassette Test, Item No. CPSP-10PPX; ProScreen 10 Panel Cup, Item No. PSCup-10MMO-300, PSCup-10M, PSCupA-10MO, PSCUp-10AB; ProScreen 10 Panel Cup with Adulterants, Item No. PSCupA-10AM; ProScreen 10 Panel Dip Card, Item No. PSD-10MMO-300, PSD-10MOX, PSD-10M, PSD-10CMO3, PSD-10APO-300; ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO-300; ProScreen 11 Panel Dip Card, Item No. PSD-11MT; ProScreen 12 Drug Cup w/Adulteration, Item No. PSCupA-12TBU; ProScreen 12 Panel Cup w/Adult., Item No. PSCupA-12M, PSCupA-12PP; ProScreen 12 Panel Dip Card, Item No. PSD-12BUP ProScreen 5 Panel Dip Card, Item No. PSD-5MB; ProScreen 5 Panel Dip Card w/Adult, Item No. PSDA-5MB-300; ProScreen 6 Panel Cassette w/Adult (AU), Item No. PSPA-6MBAU; ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU; ProScreen 6 Panel Dip Card, Item No. PSD-6MBO, PSD-6MTDBO-300, PSD-6MB, PSD-6BUPO; ProScreen 7 Panel Dip Card, Item No. PSD-7MO, PSD-7M; ProScreen 8 Panel Dip Card, Item No. PSD-8P; ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P; ProScreen 9 Panel Dip Card, Item No. PSD-9P; ProScreen CLIA Waived Cup 6 Drugs w/Adul, Item No. PSCupA-6MB-W; ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W; ProScreen CLIA Waived Cup with 8 Drug, Item No. PSCup-8P-W; ProScreen Cup, Item No. PSCup-6MB-W, PSCupA-6MB-W, PSCup-6BO-W, PSCup-8P-W, PSCUp-10AB, PSCup-10MMO-300; ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W; These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.     134545 150270 150542 134346 134347 141739 141836 141841 142565 142951 143151 143875 144102 144106 144239 144241 144362 150192 150198 150629 150630 150651 150791 150959 151037 151358 151359 143402 143813 144240 151395 134181 141028 141458 142039 142111 142385 142396 142498 142717 142823 142957 142972 143514 143828 144298 144301 144308 144309 144310 144519 144520 144540 144541 150087 150108 150145 150169 150514 150516 150639 150810 151018 151523 151524 143574 143947 145055 150037 150187 150310 150457 150660 150881 150941 151465 151468 142864 150051 150512 141889 144364 150792 141747 142054 144104 144363 150689 151066 151067 142284 150208 150509 150643 150936 140904 141374 141527 141746 144261 144537 151282 151295 144336 150879 G150042 G140426 G150017 G150048 G150069 G150111 G150146 140905 140906 141014 141027 141225 141228 141347 141440 141446 141510 141740 141742 141751 144334 144335 144539 144545 144546 150148 150154 150168 150232 150462 150478 150601 150602 150653 150808 150938 151283 142514 143150 143404 143858 144394 144440 150482 150513 150904 151372 142528 143154 143405 150339 151297 150050 142529 142971 143155 143474 144547 150286 150654 150786 143803 150003 150207 150828 143874 144562 150182 150231 150325 141296 141372 141475 141476 141583 141842 143825 144227 Class II Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Ameditech Inc
Devices The Drug Detection Agency 6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.     G140422-C G150059-C G150063-C G150132-C Class II Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Ameditech Inc
Devices THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU, MTPA-8MBAU These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.     G150094 G150136 Class II Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Ameditech Inc
Drugs Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-034-01) and b) 1000 Ct Bottles (NDC: 49884-034-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977. a) Lot #: 24820001, Expiry: NOV 2015; Lot #: 25783601, Expiry: OCT 2016; Lot #: 25783801, Expiry: OCT 2016; Lot #: 26731201, Expiry: AUG 2017; Lot #: 26762002, Expiry: FEB 2018. b) Lot #: 26683201, Expiry: AUG 2017; Lot#: 26762001, Expiry: FEB 2018. Class III Failed Impurities/Degradation Specifications: Out of specification for impurities. Par Pharmaceutical Inc.
Drugs Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-035-01) and b) 1000 Ct Bottles (NDC: 49884-035-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977. a) Lot #: 25552101, Expiry: AUG 2016; Lot#: 25712701, Expiry: SEP 2016; Lot  ...
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Class III Failed Impurities/Degradation Specifications: Out of specification for impurities. Par Pharmaceutical Inc.
Devices ECG Out Cable, for use with a Philips ALS monitor/ defibrillator and bedside monitor for Synchronized cardioversion and Transcutaneous pacing. M1783A/M5526A 12-pin Sync cables, used with HeartStart MRx and HeartStart XL and HeartStart XL+ All Philips M1783A and M5526A sync cables are affected by this issue. The model number is printed on the outside of the cable, near the end with the ¼ inch phone plug. Class II When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync cable, the following can occur if the monitor/defibrillator experiences interference from electrical fast transients (EFTs) while connected to AC power: On the HeartStart MRx and HeartStart XL, EFT noise can be misinterpreted as an R-wave. On the HeartStart XL+, EFT noise can disable ECG monitoring, and potentially interrupt demand mode pacing. Philips Electronics North America Corporation
Devices Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use in the Preparation of acid concentrate for hemodialysis. All 132 Gallon Granuflo Dissolution Units and 132 Gallon Dry Acid Dissolution Units with the H218 Motor and Modified H218 Mixer Motors. Class II Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire. Fresenius Medical Care Renal Therapies Group, LLC
Devices Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the Preparation of acid concentrate for hemodialysis. All 132 Gallon Granuflo Dissolution Units and 132 Gallon Dry Acid Dissolution Units with the H218 Motor and Modified H218 Mixer Motors. Class II Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire. Fresenius Medical Care Renal Therapies Group, LLC
Devices Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075. For Use in the Preparation of acid concentrate for hemodialysis. All 132 Gallon Granuflo Dissolution Units and 132 Gallon Dry Acid Dissolution Units with the H218 Motor and Modified H218 Mixer Motors. Class II Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire. Fresenius Medical Care Renal Therapies Group, LLC
Food USFX Granny Smith Apples 175ct apples. Unit Size: Case/ Cardboard Carton, SKU 0244. Lot Numbers: 5, 17, and 86 Class II Northstar Produce Inc. is recalling 98 cases of Granny Smith apples because a test performed on a sample of the apples indicated the presence of Listeria monocytogenes, Salmonella, and / or Enterohemorrhagic E. coli. Northstar Produce Inc.
Devices Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intra-hospital transport. All models manufactured prior to 2015 are affected Class I A component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming. Event Medical LTD
Biologics Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated W2869150030531 (double collection); W117015048874G; W1170150408608; W117015050899K; W117015056023S; W287015003222V Class III Apheresis blood products, incorrectly labeled as having an extended expiration date, were distributed. Blood Centers of the Pacific - Irwin Center
Food Mountain Mix 2oz bag, 7oz pouch, 10oz pouch, 17oz tin, 28oz pouch & 25lb bag. INGREDIENTS: Raisins, Peanuts (Peanuts, Peanut and/or Canola Oil, Salt), Choco Buttons (Sugar, Partially Hydrogenated Vegetable Oil [Contains One or More of the Following: Palm Kernel***Produced in a facility that processes peanuts and other nuts. Sold under the brand names of Better Valu, Clear Value, Favorite, King's & Valu Time. KING'S MOUNTAIN MIX 2 OZ. PILLOW BAG UPC0 38445 00224 2, Item #00229 Julian Date: 5014, 5028, 5049, 5065, 5097, 5104, 5105, 5140, 5141, 5155, 5156, 5196, 5224, 5229, 5230, 5266, 5267 & 5286. FAVORITES MOUNTAIN MIX 7 OZ. STAND UP POUCH UPC 0 38445 12280 3, Item #12080 Best By:  ...
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Class I The firm was notified that the product contains undeclared Milk. Kanan Enterprises, Inc.
Food Sweet & Salty Mix 2.75oz Tube Bag, 5oz Pillow Bag, 6.5oz Pillow Bag, 8oz Stand Up Pouch, 16oz Plastic Jar & 25lb Case. INGREDIENTS: Peanuts (Peanuts, Canola and/or Peanut oil, Salt), Chocolate Buttons***Contains Peanut. Sold under the brand names of: Choice, Speedy & King's. SPEEDY CHOICE TRAIL MIX SALTY & SWEET 2.75 OZ. TUBE BAG, UPC 0 52894 12062 3 Item # 12077 Best  ...
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Class I The firm was notified that the product contains undeclared Milk. Kanan Enterprises, Inc.
Food Kings fresh & Delicious Cashews & Sweeties Net Wt. 14oz. (397g) INGREDIENTS: Cashews (Cashews, Canola and/or Peanut Oil Salt), CHOCOLATE BUTTONS (Sugar, Partially Hydrogenated Palm Kernel***King Nut Companies Solon, OH 44139 www.kingnut.com 0 38445 49999 8 Item #649999 Julian Date: 5012, 5028, 5036, 5079 & 5252. Class I The firm was notified that the product contains undeclared Milk. Kanan Enterprises, Inc.
Devices Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with PCA Acetabular Shells and Femoral Heads to restore hip joint biomechanics. Catalog Number:Lot Number; 6299-8-403:23182601; 6299-8-469:19123701; 6299-8-525:29115601; 6299-8-525:22727301; 6299-8-581:17772401; 6299-8-581:28432001. Class II Six (6) PCA 10 Degree Hooded Acetabular Insert-Duration 22 mm (ID) have been distributed in the US, although the 22 mm size was inadvertently omitted from 510(k) #K963612. Stryker Howmedica Osteonics Corp.
Food NatureBox Sticks 'n Stones; roasted nuts with sesame sticks 4.5 oz (128 g) pouches - UPC 8 52523 00546 4 and 5 lb. Corporate bags - no UPC; Ingredients: Sesame Sticks (unbleached flour, malted barley flour, soybean oil, sesame seeds, bulgar wheat, salt, beet powder, turmeric), Cashews, Almonds, Peanut Oil, Salt. Contains: Wheat and Tree Nuts (Cashews and Almonds). Packed in a facility that also processes tree nuts, peanuts, milk, wheat, egg, soy and fish, Distributed by: NatureBox, San Carlos, CA 94070 4.5 oz bags: Lot MWA2 123015; Best by 12/30/15; MWA1 123015; Best By 12/30/2015; 2BC15230; Best By 12/30/2015; 5 lb. corporate bags: B5C15206, Best By 12/30/2015. Class II Supplier notified firm that the oil used to roast nuts for a trail mix product had also been used to roast peanuts, leading to the possibility of peanut contamination. Peanuts were not listed in the allergen statement. NatureBox, Inc.
Food Herr's Sour Cream & Onion Flavored Potato Chips UPC No. 7260000061 for all the following Lot Numbers: Jan 2 2016D Jan 9 2016B A Jan 9 2016 C Jan 9 2016 Jan 16 2016 A Jan 16 2016 B Jan 16 2016 E D Jan 23 2016 Jan 23 2016 A Jan 23 2016 C Jan 30 2016 C Class II Herr Foods Inc. has initiated a voluntary recall of certain bags of its 1.875 oz. Sour Cream and Onion flavored Potato Chips due to a packaging error that incorrectly states that the product is gluten free. While the back panel of the package complies with U.S. Food & Drug Administration (FDA) label regulations by listing Wheat in the ingredient statement as well as Contains Wheat in its related allergen statement, the front panel of the package erroneously features the words Gluten Free. Gluten is the protein that naturally occurs in wheat, rye, barley, and crossbreeds of these grains. Most people can eat gluten, but in people with celiac disease, gluten intake gradually damages the intestines, prevents the absorption of vitamins and minerals, and can lead to other health problems. Symptoms can include diarrhea, fatigue, headaches, abdominal pain, brain fog, rashes, nausea, vomiting, and other reactions. Herrs has not received any reported illnesses to date. Herrs Sour Cream & Onion Potato Chips, 1.875 oz. bags only, were distributed nationwide through retail stores, distributors, and internet sales. These products were sold as individual bags. No other bag sizes of Herrs Sour Cream N Onion Chips are involved with this recall. No other Herrs products are involved with this recall. Herrs Foods Inc
Food 7" Publix Bakery - German Chocolate Layer Cake. Product is shipped in cases containing 6 individual cakes. Maplehurst Code: 085421; Publix Code: 117924 - German Choc Banded; Lot Code: 5273D10854110 Class I German Chocolate cake labeled with incorrect ingredient declaration. Label was for Cookies and Creme cake as opposed to German Chocolate cake ingredient and allergen declaration. Maplehurst Bakeries, LLC.
Devices MiniArc Pro" Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence. Lot number 936405. Serial numbers 936405001 through 936405056 Class II The lot number on the outer carton label did not match the lot number printed on the tray label or identification labels inside the box. The identification labels inside the box are placed on medical records and other documents associated with the procedure. Use of incorrectly identified labels may prevent direct traceability of the implanted unit in the future. Astora
Devices ECG Electrodes: 50007  Stablebase SBW55 50675  Stablebase SBW55-15 58051  Skintact W-60 50547  Stablebase SBT60 Only OUS: 50476 Skintact W-60HP E3 I 58046 Skintact T-60 I Patz K920 58688 Dahlhausen 1900000440 59629 Cardionetics CN-15-W60 58789 Lessa 99.832.02 58872 EF Medica FS 50 LG 50359Ultragel FS50LG List of models and lot numbers - USA Artikel No. Brand / Model Lot Nos. Skintact W-60 (30/1200) 58051 Skintact W-60 (30/1200) 31113-0159 58051 Skintact W-60 (30/1200) 40304-0324 58051 Skintact W-60 (30/1200) 40325-0153 58051 Skintact W-60 (30/1200) 40326-0154 58051 Skintact W-60 (30/1200) 40416-0326  ...
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Class II There is a risk ECG electrodes of specific lots fail to transmit signals. There is a risk that the affected electrodes will transmit a poor signal or no signal at all before reaching the indicated expiration date. Leonhard Lang Medizintechnik GmbH
Drugs c-Budesonide 0.6MG capsules, 60-count bottle, NOT FOR ORAL USE-USE IN NASAL RINSE OR NEBULIZER, SOLUTIONS Rx PHARMACY, 2705 4TH AVENUE SOUTH, BIRMINGHAM, AL 35233 Lot #: 04-24-2015-D, Exp 05/31/15; 03-13-2015-C, 03-18-2015-F, 03-18-2015-G, 03-23-2015-C, 03-24-2015-C, 04-02-2015-G, 04-14-2015-F, 04-14-2015-G, 04-22-2015, 05-06-2015-B, 05-14-2015-D, 05-22-2015-F, 05-27-2015-C, 06-02-2015-E, 06-10-2015-J, Exp 06/16/15 Class II Penicillin Cross Contamination - Possible presence of penicillin in bulk budesonide powder used to compound prescription nasal rinse/nebulizer capsules. Solutions Rx Pharmacy
Drugs Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tablet Blister Pack Packages, Rx Only. Manufactured by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977. Mylan. NDC: 51079-090-20. Lot #: 3060153, Expiry: 08/31/16 Class III Failed Impurities/Degradation Specifications: Out of specification for impurities. Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Biologics FLULAVAL QUADRIVALENT Carton NDC 19515-894-52 Syringe NDC 19515-894-41 2B472AFLHA839A; 42N4LAFLHA822A; 5AZ7HAFLHA820A; 9A3ZMAFLHA841A; ZS95ZAFLHA821A; A2PK7AFLHA821A; AR57JAFLHA832A; DR4GFAFLHA847A; YF5DTAFLHA847A; F45C5AFLHA842A; T3J4SAFLHA819A; XP4J2AFLHA819A; 379MYAFLHA833A; Class III Certain lots of FLULAVAL QUADRIVALENT, with observed loss of potency below the minimum specification prior to product expiry, were distributed. ID Biomedical Corp., a subsidary of GSK Biologicals
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