• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of February 24, 2016

  • Print
  • Share
  • E-mail
-
Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Drugs CITRULLINE (L) in 25 g, 100 g, 500 g and 1 kg plastic bottles, White crystals or crystalline powder, odorless, For Use and distribution in prescription compounding, manufacturing, processing, or repackaging only in accordance with FDA regulations and applicable law, Packaged by Medisca Inc. Plattsburgh, NY 12901, USA, NDC #s: 38779-1186-4 (25 g), 38779-1186-5 (100 g), 38779-1186-8 (500 g), 38779-1186-9 (1 kg). Lot #s: 95482/A, 95482/B, 95482/C, 95482/D, 96453/A, 96453/B, 96453/C, and 96453/D, Exp. 10/31/2014 Class I Labeling: Label Mix-Up: FDA tested samples of API from Medisca, labeled as to contain L-Citrulline, and results revealed no L-Citrulline was present. Levels of N-acetyl-leucine were found instead. Medisca Inc
Food Mung bean sprouts packaged in 10 lb., 15 lb., and 30 lb. plastic bags. There are no product or production codes associated with these products. Class I Listeria monocytogenes was found in the mung bean sprouts and the area where the sprouts are produced. Wholesome Soy Products
Devices GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5). GVL: The GlideScope Video Laryngoscope is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rechargeable lithium battery, and video output to a remote monitor. It consists of a video laryngoscope and a portable video monitor. AVL: The GlideScope AVL Video Monitor system has the same intended use as the GVL System. The difference between systems is that the AVL has a digital platform and the GVL an analog platform. Affected GVL Reusable Blades Serial Numbers, by Part Number GVL 3- 0574-0007: MD131859- MD151622; GVL 4- 0574-0001: LG131994- LG151773; GVL 5- 0574-0030: XL131577- XL151524. Affected AVL Reusable Blades Serial Numbers, by Part Numbers: AVL 2- 0574-0118: AC131852- AC151510; AVL 3- 0574-0115: AD131589- AD151506; AVL 4- 0574-0116: AE131586- AE151558; AVL 5- 0574-0117: AF131503- AF151500. Class II Verathon has revised the Operations and Maintenance Manual (OMM) to specifically state compatibility limitations of the reusable video laryngoscope Blade validated through simulated use cycles, such that exceeding this number of cycles in the specific chemical agent may affect the potential life of the product. Verathon, Inc.
Devices Actuator for angiographic x-ray monitor ceiling suspension system. Actuator short Assy: THC8AWDS-121 and Actuator long Assy: THC8AWDS-122 used with the following products: 722001 Allura Xper FD 10 C; 722003 Allura Xper FD10; 722005 Allura Xper FD10/10; 722006 Allura Xper FD20; 722008 Allura Xper FD20 Biplane; 722010 Allura Xper FD10; 722011 Allura Xper FD10/10; 722012 Allura Xper FD20; 722013 Allura XPER FD20 BIPLANE; 722015 Allura Xper FD20 OR Table; 722020 Allura Xper FD20 Biplane OR Table; 722022 Allura Xper FD10 OR Table; 722023 Allura Xper FD20 OR Table; 722025 Allura Xper FD20 Biplane OR Table; 722026 Allura Xper FD10; 722027 Allura Xper FD10/10; 722028 Allura Xper FD20; 722029 Allura Xper FD20/10; 722035 Allura Xper FD20 OR Table; 722038 Allura Xper FD20/20; 722039 Allura Xper FD20/20 OR Table; 722058 Allura Xper FD20/15; 722123 Field extensions Xper cardio R7.6; 722124 Field extensions Xper vascular R7.6; 722133 Field ext. Xper cardio systems R7.6; 722134 Field ext. Xper vascular systems R7.6; 72249 INTEGRIS BV5000; 722043 INTEGRIS Allura 15-12 (mono); 722121 Field extensions INTEGRIS cardio systems Actuator short Assy: THC8AWDS-121 and Actuator long Assy: THC8AWDS-122 Class II The actuator assembly became detached and the monitor carriage with a flexvision monitor dropped to its lowest position. Philips Electronics North America Corporation
Drugs Akttive High Performance Fat Burner Gold dietary supplement capsules, 30-count bottle, Distributed by Life and More, L.L.C., Doral, Florida Lot # 000815004400; Exp 12/17 Class I Marketed Without An Approved NDA/ANDA: Dietary supplements contains undeclared sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling. Life and More LLC
Food RED DIAMOND, COLOMBIAN, NATURALLY CAFFEINATED, Coffee Concentrate, Mix Ratio 69 + 1, Net contents 1/2 Gallon, Manufactured for RED DIAMOND, Birmingham, AL; Item # 111589 ALL CODES Class II Elevated pH levels in an acidified product Red Diamond, Inc.
Food RED DIAMOND, European Roast, COFFEE CONCENTRATE, Mix Ratio 69 + 1, Net contents 1/2 Gallon, Manufactured for RED DIAMOND, Birmingham, AL; Item # 111590 ALL CODES Class II Elevated pH levels in an acidified product Red Diamond, Inc.
Food RED DIAMOND, COLOMBIAN, NATURALLY DECAFFEINATED, Coffee Concentrate, Mix Ratio 69 + 1, Net contents 1/2 Gallon, Manufactured for RED DIAMOND, Birmingham, AL; Item # 111591 ALL CODES Class II Elevated pH levels in an acidified product Red Diamond, Inc.
Drugs ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets, 500 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 60060, NDC 53329-641-30. lot # 45810; Exp. 05/18 Class I Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets. Medline Industries Inc
Drugs ACETAMINOPHEN REGULAR-STRENGTH PAIN RELIEVER tablets, 325 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 60060, NDC 53329-642-30. lot # 45810; Exp. 05/18 Class I Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets. Medline Industries Inc
Drugs fentaNYL Citrate, Preservative Free, 5 mcg per mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV Use, packaged in a 3 mL syringe, code 2R3479, PharMEDium. Lot #: 15002077M, Exp 04-02-2015 Class I Subpotent Drug Pharmedium Services, LLC
Drugs fentaNYL Citrate, Preservative Free, 10 mcg per 1 mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV Use, packaged in a 3 mL syringe, code 2R3174, PharMEDium Lot #: 15002250M, Exp 04-02-2015 Class I Subpotent Drug Pharmedium Services, LLC
Drugs Rhino 7 3000, 6 count bottles, Distributed by Rhino 7, Made in USA. All Lots Class I Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine. MSNV, Inc dba National Video Supply
Drugs Rhino 7 Platinum 3000, Single Blister Packs, distributed By Rhino 7, Made in USA All Lots Class I Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine. MSNV, Inc dba National Video Supply
Drugs Rhino 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA All lots Class I Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine. Premiere Sales Group
Drugs Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA All lots Class I Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine. Premiere Sales Group
Drugs NATUREAL BURN FAT NATURE, 30-count capsules, packaged in clear plastic bottle, Manufactured for: Inaffit, LLC. P.O. Box 34056, Bethesda, MD 20827. All lots Class I Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine. Inaffit, LLC
Food 100% Whole Grain Hot Dog Rolls Bakery Code: 09, Julian Code: 304, 305, Fresh Through Code: 11-11, 11-12 Class II Possible presence of plastic Bake Rite Rolls Divison of Northeast Foods
Drugs Paricalcitol Capsules, 1 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-663-30 Lot #s: C404795, C404796, C404797, Exp 05/2016; C406272, C406273, C406274, C406518, Exp 07/2016; C409586, C409587, Exp 11/2016; C409588, Exp 12/2016; C501835, C501836 , C501837, Exp 02/2017; C503797, C503798, Exp 05/2017; C505009, Exp 06/2017; C505568, C505569, Exp 07/2017 Class III Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules. Dr. Reddy's Laboratories, Inc.
Drugs Paricalcitol Capsules, 2 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-664-30 Lot #s: C404653, C404654, C404655, Exp 05/2016; C505010, Exp 06/2017 Class III Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules. Dr. Reddy's Laboratories, Inc.
Drugs Paricalcitol Capsules, 4 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-665-30 Lot #s: C404440, Exp 04/2016; C404946, Exp 05/2016; C505704, Exp 07/2017 Class III Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules. Dr. Reddy's Laboratories, Inc.
Food Wegmans ITALIAN CLASSICS BUTTERNUT SQUASH RAVIOLI, NET WT 9 OZ, UPC #77890 36434, KEEP REFRIGERATED, PRODUCT OF ITALY All date codes Class I Wegmans Food Markets, Inc. initiated a recall due to the presence of undeclared tree nuts (Cashews and Almonds) Wegmans Food Markets, Inc.
Food Swai Fillets ( 7-9 oz.) packaged in a 15 lb. blue and white box with blue and white lettering. Production date: 08/19/2015; Best used by date: 08/19/2017; PO No: 429-13385 Class III Nitrofuran (SCA) was found in the product during routine third party lab testing. Restaurant Depot/Jetro
Food B&D Seafoods Basa Choice Swai Fillets IQF 15 lbs x 1/case (size 5-7, 7-9, 9-11), 11 lbs 2/case (size 6-8) Farm Raised Distributed by B&D Seafoods, Inc. Product of Vietnam IQF well trimmed, boneless, skinless, belly off, fat off, red meat off Products are packaged in cardboard boxes. Lot Numbers: 429-13385, 429-13388 Production Date: June 26, 2015 Class III B&D Seafoods, Inc. is recalling frozen swai fillets due to the presence of nitrofurans. B & D Seafoods Inc
Food Pacific Surf Swai Fillets IQF 2 lbs x 5/ctn, 5 lbs x 6/ctn (size 7-9) Farm Raised Product of Vietnam Packed for: PAFCO Global Seafood Services IQF well trimmed, boneless, skinless, belly off, fat off, red meat off Products are packaged in cardboard boxes. Lot Numbers: 257699, 4850 Class III B&D Seafoods, Inc. is recalling frozen swai fillets due to the presence of nitrofurans. B & D Seafoods Inc
Food Happy Fish Swai Fillet Farm Raised Produc tof Vietnam Net Weight: 22 lbs IQF well trimmed, boneless, skinless, belly off, fat off, red meat off Products are packaged in cardboard boxes. Production Date: 08/19/2015 Best By: 08/19/2017 Class III B&D Seafoods, Inc. is recalling frozen swai fillets due to the presence of nitrofurans. B & D Seafoods Inc
Drugs Vitamin Supplement (Vial) D3, (cholecalciferol (vit D3)/lipoic acid/ubiquinol/ methylcobalamin/pyridoxine/methionine/inositol/choline bitartrate USP) capsules, 60, 120 or 180 count vials, Glades Drugs, 109 S. Lake Ave., Pahokee, FL 33476. AICACABF@3, AICECABF@2, AJBFCABF@4, ABCCABF@4, AICACABF@5, AICECABF@3, AJBHCABF@2, ABCCABF@5, AICBCABF@1, AICECABF@4, AJCBCABF@1, ABGCABF@4, AICBCABF@2, AICECABF@5, JCBCABF@2, BACDCABF@5, AICBCABF@3, AICICABF@3, BAAGCABF@2, BADACABF@3, AICBCABF@4, AJADCABF@1, BAAICABF@1, BACCABF@3, AICECABF@1, AJBECABF@6, BABCCABF@2 and BBAECABF@5, Exp 02/20/2016 Class I Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecalciferol). Glades Drugs Inc.
Devices Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle Ref: EGIAUSHORT Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers when used with the Endo GIA curved tip single use reloads can be used to blunt dissect or separate target tissue from other tissue. RANGES OF LOT NUMBERS (all lot numbers within each range are affected) Lot # starting with P3C through P5B0289X P5C0196X through P5C0197X P5C0304X through P5C0307X P5C0796X through P5C0798X P5D0049X through P5D0051X P5D0146X through P5D0148X P5E0261X through P5E0262X P5F0158X through P5F0161X INDIVIDUAL LOT NUMBERS (in addition to ranges) N3F0260RX N3F0266RX N3F0267RX  ...
More
Class II Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use Medtronic
Devices Covidien Endo GIA Ultra Universal Standard Stapler Handle Ref: EGIAUSTND Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers when used with the Endo GIA curved tip single use reloads can be used to blunt dissect or separate target tissue from other tissue. RANGES OF LOT NUMBERS (all lot numbers within each range are affected) Lot # starting with P3C through P5B0521X P5D0410X through P5D0411X P5D0823X through P5D0829X P5E0080X through P5E0082X P5E0317X through P5E0320X P5E0322X through P5E0324X P5F0001X through P5F0002X INDIVIDUAL LOT NUMBERS (in addition to ranges) P5C0239X, P5C0241X, P5C0508X, P5C0510X, P5C0512X, P5C0597X  ...
More
Class II Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use Medtronic
Devices Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle Ref: EGIAUXL Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers when used with the Endo GIA curved tip single use reloads can be used to blunt dissect or separate target tissue from other tissue. Lot numbers within each range are affected: Lot # starting with P3C through P5B0454X, P5B0468X, P5C0152X through P5E0450X. Individual Lot Number: P5B0468X, P5E0523X, P5E0273X Class II Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use Medtronic
Devices Best Practice Kits containing certain production lots of Endo GIA Ultra Universal Stapler Handles Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers when used with the Endo GIA curved tip single use reloads can be used to blunt dissect or separate target tissue from other tissue. Kit Lot numbers: 00B0203 00Z1924 00Z1992 00Z1993 00Z2030 00Z2062 00Z2063 00Z2072 00Z2081 00Z2090 00Z2098 00Z2117 00Z2119 00Z2121 00Z2122 00Z2123 00Z2124 00Z2129 00Z2130 00Z2133 00Z2138 00Z2139 00Z2143 00Z2145 00Z2146 00Z2147 00Z2148 00Z2150 00Z2151 00Z2152 00Z2153 00Z2154 00Z2155 00Z2159 00Z2160 00Z2161 00Z2163 00Z2164 00Z2166 00Z2167 00Z2171 00Z2172 00Z2174 00Z2175 00Z2176 00Z2177 00Z2179 00Z2181 00Z2182 00Z2183 00Z2184 00Z2187 00Z2190 00Z2191 00Z2192 00Z2193 00Z2194 00Z2198 00Z2199 00Z2200 00Z2201 00Z2208 00Z2209 00Z2211 00Z2212 00Z2213 00Z2216 00Z2217 00Z2220 00Z2221 00Z2222 00Z2223 00Z2224 00Z2225 00Z2233 00Z2234 00Z2237 00Z2243 00Z2244 00Z2245 00Z2249 00Z2252 00Z2254 00Z2255 00Z2265 00Z2268 00Z2272 00Z2273 00Z2287 00Z2289 00Z2304 00Z2305 00Z2306 00Z2312 00Z2315 00Z2321 00Z2322 00Z2323 00Z2325 00Z2326 00Z2327 00Z2328 00Z2351 00Z2352 00Z2353 00Z2367 00Z2391 00Z2392 00Z2396 00Z2432 00Z5001 00Z5001A BARIATRICRR1 BARIATRICRR5 BARIATRICRR7 ENDOBARIATRICR ENDOBARIATRICS ENDOTHORACICL ENDOTHORACICS ENDOTHORACICW THORACICRR1 00Z2363 00Z2364 00Z2387 Class II Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use Medtronic
Devices Bond Polymer Refine Red Detection DS9390 kits. The common name of the device is detection system for in vitro diagnostic use. The Intended Use states that Bond Polymer Refine Red Detection is a biotin-free, polymeric alkaline phosphatase (AP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies. It is intended for staining sections of formalin-fixed, paraffin-embedded tissue on the BOND automated system. Product Code DS9390 with lot numbers 41203, 41407, 41478, 41575, 41619, 41779, 41872, 42027, 42105, 42172, 42181, 42251, 42345, 42397, 42512 and 42594. Class II The Firm informed the importer/distributor, Leica Microsystems, a manufacturing error occurred during the filling of some containers of the Bond Polymer Refine Red Detection DS9390 kits, which may result in inadequate staining. Leica Microsystems, Inc.
Biologics Source Plasma WN0484214; Class III Blood product, in which donor screening/donor record incomplete or incorrect, was distributed. DCI Biologicals Wilmington, Inc.
Drugs Ultimate Herbal Slimcap Capsules, 350 mg*, 30-count bottles, labeled Part 1 of 3, fit firm & fabulous, UPC 5 42423 25422 1. Lot #: 05/02/2015 to 05/01/2017 Class I Marketed Without An Approved NDA/ANDA: product marketed as a dietary supplement was found to be tainted with undeclared sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug. Fit Firm and Fabulous
Food Marky's Puto Seko Special, Net Wt. 200 GMS Lot #LO318MO35C15 with best before date of 4/10/2016 Class II Lee Food Corporation is recalling Marky's Puto Seko Special because the product contains undeclared colors, FD & C Blue #1, Yellow #5 and Yellow #6 and also unallowable dye - Amaranth (E123). Lee'S Food Corp
Food Dried Tai Sweet Mango Slice, Net Wt: 8 oz., UPC 6 944155 210102 N/A Class I AA USA Trading Inc. is recalling Dried Tai Sweet Mango Slice (NYSDAM FL: 378858) because the product contains undeclared FD&C Yellow #6 and Dried Kiwi Slice (NYSDAM FL: 378859) because this product contains undeclared FD&C Blue #1, Yellow #5 and undeclared sulfites. AA USA Trading Inc.
Food Dried Kiwi Slice, Net Wt: 8 oz., UPC 6 944155 210041 N/A Class I AA USA Trading Inc. is recalling Dried Tai Sweet Mango Slice (FL 378858) because the product contains undeclared FD&C Yellow #6 and Dried Kiwi Slice (FL 378859 because this product contains undeclared FD&C Blue #1, Yellow #5 and undeclared sulfites. AA USA Trading Inc.
Devices High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessories are indicated for use in access of the joint capsule. 50209581 50220887 50231401 50216929 50226220 50231932 50218285 50229266 50235063 50240019 50245683 50251109 50254562 50256942 50263784 50279382 50291593 50302984 50303418 50327069 50330377 50351345 50361381 50404796 50408768 50419699 50433964 50250837 50256854 50269580 5027766 50304642 50342002 50401593 50417254 Class II During arthroscopic surgery, when the scope is moved inside the cannula, the body of the irrigation extender separates, potentially obstructing visualization and causing leakage of the irrigation fluid. The device is removed and a back-up device is used to complete the surgery. Smith & Nephew, Inc., Endoscopy Div.
Biologics Red Blood Cells, Leukocytes Reduced W270115507643; Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Central Pennsylvania Blood Bank
Devices REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single Use, Rx Only, Latex Free, 50 units. Product Usage: Product is intended for Resectoscope irrigation, catheter irrigation and Foley catheter inflation. Lot Number NGZE1190 Class III Report by a customer of an open package seal. C.R. Bard, Inc.
Biologics Apheresis Platelets, Leukocytes Reduced W142815042638B; Class II Blood product, in which quality control and distribution of product did not meet specifications, was distributed. Blood Systems, Inc. dba UBS -Coast
Biologics Red Blood Cells W050911030463; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Biologics Fresh Frozen Plasma W050911030463; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Biologics Red Blood Cells W050911030473; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. HCSC-Blood Center
Biologics Fresh Frozen Plasma W050911030473; Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed HCSC-Blood Center
Food Baked, W/WO Icing Soft Pretzel in rigid plastic labeled as: New Year's Pretzel Sell By: 01/04/2016 PLU: 39739 UPC: 23979 80499 Sell By: 01/04/2016 Class I Product contained undeclared walnuts Giant Eagle, Inc.
Drugs Magnesium Sulfate in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL, 2 g Total, 50 mL Single-Dose Container bag, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6729-24. Lot: 53-113-JT, Exp 1NOV2016 Class I Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium. Hospira Inc.
Drugs APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL USA; UPC 7 05105 96361 7. All lots Class I Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug. Nuway Distributors, LLC
Devices EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator's Manual. In vitro diagnostic Product Usage: EVOLIS Microplate System is a 4 plate fully integrated microplate processing system designed for use with multiple EIA assays. The EVOLIS Microplate System instrument is not lot controlled, however for traceability purposes each instrument is assigned a unique serial number. SERIAL NUMBERS: 9163700126, 9163700175, 9163700187, 9163700196, 9163700208, 9163700210, 9163700231, 9163700266, 9163700278, 9163700320, 9163700328, 9163700336, 9163700337, 9163700349, 9163700354, 9163700368, 9163700402, 9163700431, 9163700449, 9163700478, 9163700480, 9163700481, 9163700495, 9163700498, 9163700499, 9163700501, 9163700510, 9163700527, 9163700530,  ...
More
Class II The error "Washer Reagent Clean Fluid" level low alarmed, which prompted the customer to open the system drawer. When the system drawer was opened the customer noted the plate transport was still running and as a consequence the plate was pushed off the plate transporter. Bio-Rad Laboratories, Inc.
Cosmetics Kleancolor Bow-Tux Volumizing Mascara 10.94 ml UPC Codes: 8-10236-00878-3 LOT NUMBER: GMX414A Item number: MS1878 Class II Genosco dba Kleancolor is recalling Kleancolor Lash Bow-Tux Volumizing Mascara because of potential Bacillus cereus, Staphylococcus epidermidis, and Staphylococcus warneri contamination. Genosco DBA Kleancolor
Biologics Apheresis Platelets, Leukocytes Reduced, Irradiated W2009158517581; W2009158517583 Class III Apheresis products, collected on an instrument undergoing equipment qualification, and for which quality control testing was not performed, were distributed. American Red Cross Blood Services
Biologics Apheresis Platelets, Leukocytes Reduced W2009158517582 Class III Apheresis products, collected on an instrument undergoing equipment qualification, and for which quality control testing was not performed, were distributed. American Red Cross Blood Services
Biologics Apheresis Platelets, Leukocytes Reduced, Irradiated W2009158517651; W2009158517652; W2009158517653 Class II Apheresis products, collected on an instrument undergoing equipment qualification, and for which quality control testing was not performed, were distributed. American Red Cross Blood Services
Devices Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Surgery Device. Product Usage: The Acapella One Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Is to be used with autogenous bone graft and supplemental internal fixation and is implanted via an open anterior approach. Catalog # 05-090-02-1610 // Expiration 07/2023 Serial #'s: 4053365, 4053366, 4053367, 4053368, 4053369, 4053370, 4053371, 4053372, 4053373, 4053374, 4053375, 4053376, 4053377, 4053378, 4053379, 4053380, 4053381, 4053382, and 4053383 Class II Incorrect external and internal packaging labels. Exactech has identified nineteen (19) Acapella One Interbody Fusion Device Lordotic (05-090-01-1610) were packaged as Acapella One Interbody Fusion Device Parallel (05-090-02-1610) Exactech, Inc.
Food Uncle Buck's Fish Batter Mix Original, packaged in 22 oz. (623 g) plastic bottles, bottle lot #09241505, UPC 09229725284 and packed 12 bottles/case. Bottles were shipped in cases under lot #09241506 and lot #09241507. Produced and Packaged in the USA for Bass Pro Shops By Monogram Food Solutions, LLC, Memphis, TN 38117. bottle: lot #09241505 case: lot #09241506 and #09241507 Class I Product contains an undeclared milk ingredient. BlendTech Inc
Food Glazers Donuts, 3977904033 040337, 6 PK in cardboard bakery box (fresh). All lots manufactured prior to but not including 01/13/2016. Class II Kwik Trip, Inc. is recalling various bakery goods which might be contaminated with pieces of plastic due to using plastic contaminated ice nuggets as an ingredient. Kwik Trip Bakery
Food Plain Long Johns 9999954013, 540138 each, product shipped frozen (28 per bulk tote). All lots manufactured prior to but not including 01/13/2016. Class II Kwik Trip, Inc. is recalling various bakery goods which might be contaminated with pieces of plastic due to using plastic contaminated ice nuggets as an ingredient. Kwik Trip Bakery
Food Filled Long Johns 9999954006, 540062, 28 per bulk tote. All lots manufactured prior to but not including 01/13/2016. Class II Kwik Trip, Inc. is recalling various bakery goods which might be contaminated with pieces of plastic due to using plastic contaminated ice nuggets as an ingredient. Kwik Trip Bakery
Food Jelly Bismark 9999954008, 540088, 24 per bulk tote. All lots manufactured prior to but not including 01/13/2016. Class II Kwik Trip, Inc. is recalling various bakery goods which might be contaminated with pieces of plastic due to using plastic contaminated ice nuggets as an ingredient. Kwik Trip Bakery
Food Custard Bismark 9999954007, 540070, 24 per bulk tote. All lots manufactured prior to but not including 01/13/2016. Class II Kwik Trip, Inc. is recalling various bakery goods which might be contaminated with pieces of plastic due to using plastic contaminated ice nuggets as an ingredient. Kwik Trip Bakery
Food Triple Choc Bismark 9999954048, 540484, 24 per bulk tote. All lots manufactured prior to but not including 01/13/2016. Class II Kwik Trip, Inc. is recalling various bakery goods which might be contaminated with pieces of plastic due to using plastic contaminated ice nuggets as an ingredient. Kwik Trip Bakery
Food Cinnamon Cinnsations, 4 count Net WT 19 oz (540g), 3977953052, 530530. All lots manufactured prior to but not including 01/13/2016. Class II Kwik Trip, Inc. is recalling various bakery goods which might be contaminated with pieces of plastic due to using plastic contaminated ice nuggets as an ingredient. Kwik Trip Bakery
Food Persian, 9999954011 540112, 24 per bulk tote, frozen. All lots manufactured prior to but not including 01/13/2016. Class II Kwik Trip, Inc. is recalling various bakery goods which might be contaminated with pieces of plastic due to using plastic contaminated ice nuggets as an ingredient. Kwik Trip Bakery
Food KBS Bagel Cinnamon Crunch Bagel, 9999953939, 539160, 24 per bulk tote. All lots manufactured prior to but not including 01/13/2016. Class II Kwik Trip, Inc. is recalling various bakery goods which might be contaminated with pieces of plastic due to using plastic contaminated ice nuggets as an ingredient. Kwik Trip Bakery
Food KBS Cinn Raisin Bagel, 9999953937, 539158, 24 per bulk tote. All lots manufactured prior to but not including 01/13/2016. Class II Kwik Trip, Inc. is recalling various bakery goods which might be contaminated with pieces of plastic due to using plastic contaminated ice nuggets as an ingredient. Kwik Trip Bakery
Food KBS Plain Bagel, 9999953936, 539157, 24 per bulk tote. All lots manufactured prior to but not including 01/13/2016. Class II Kwik Trip, Inc. is recalling various bakery goods which might be contaminated with pieces of plastic due to using plastic contaminated ice nuggets as an ingredient. Kwik Trip Bakery
Devices MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc. Model #: 10000, Serial #'s: 100, 101, 102, 104 & 105 Class II The system loaded a completion fraction in the incorrect order after a treatment interruption. Viewray Incorporated
Drugs Bupivacaine, 0.25%, 450 mL, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs calcium elemental, 3 mg/10 mL, 200 mL unit: This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All Lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs Estradiol cypionate/Test cyprionate; 2 mg/50 mg/ml, unit size 5 mL, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All Lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs Folic Acid, 5 mg/mL, 30 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs Folic Acid, 10 mg/mL, 6 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All Lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs Hydroxycobalamine 30 mg/mL, 90 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All Lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs hydroxyprogesterone in sesame 250 mg/mL, 2 mL, 5 mL, 6 mL, 8 mL unit sizes, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs hydroxyprogesterone w/ pres; 1 mg/mL, 20 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs Insulin, 70/30, 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs methylcobalamine 10 mg/mL, 10 mL and 12 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All Lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs methylcobalamine 1 mg/mL, 1 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs methylcobalamine 4 mg/mL, 5 mL and 30 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs papaverine prostaglandin 30 mg/30 mcg/mL, 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs papaverine prostaglandin 30 mg/20 mcg/mL, 10 mL unit size; refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs papaverine phentolamine 30 mg/1mg/mL, 5 mL and 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs papaverine phentolamine, 35 mg/2.5 mg/mL; 5 mL unit size; refrigerate,This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs papaverine phentolamine prostaglandin; 12/0.83 mg/10 mcg/ml; 5 mL and 10 mL unit size; refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs papaverine phentolamine prostaglandin; 12/1 mg/10 mcg/mL 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs papaverine phentolamine prostaglandin; 12/1 mg/9 mcg/mL; 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs papaverine phentolamine prostaglandin; 12/1 mg/30 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs papaverine phentolamine prostaglandin; 17.16/0.57 mg/19.45 mcg/mL; 5 mLunit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs papaverine phentolamine prostaglandin; 18/0.6 mg/6 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs papaverine phentolamine prostaglandin; 22.5/0.83 mg/8.3 mcg/mL; 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs papaverine phentolamine prostaglandin; 22.5/0.83 mg/15 mcg/mL; 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs papaverine phentolamine prostaglandin; 25/0.83 mg/10 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs papaverine phentolamine prostaglandin; 25/0.83 mg/20 mcg/mL; 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs papaverine phentolamine prostaglandin; 25/1.5 mg/15 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs papaverine phentolamine prostaglandin; 25/1 mg/30 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs papaverine phentolamine prostaglandin; 30/1.5 mg/40 mcg/mL; 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs papaverine phentolamine prostaglandin; 30/1 mg/10 mcg/mL; 5 mL, 7 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs papaverine phentolamine prostaglandin; 30/1 mg/20 mcg/mL; 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs papaverine phentolamine prostaglandin; 30/2 mg/20 mcg/mL; 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs papaverine phentolamine prostaglandin; 30/2 mg/25 mcg/mL; 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs papaverine phentolamine prostaglandin; 30 mg/0.25 mg/10 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs papaverine phentolamine prostaglandin; 35/1.2 mg/20 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs papaverine phentolamine prostaglandin; 35/1.5 mg/50 mcg/mL, 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs papaverine phentolamine prostaglandin; 35/2.5 mg/1 mcg/mL, 10 mL, unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs papaverine phentolamine prostaglandin; 35/2 mg/40 mcg/mL, 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs papaverine phentolamine prostaglandin; 9/1 mg/10 mcg/mL, 10 mL, unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs progesterone/testosterone (ss oil) 0.25/20 mg/mL, 10 mL unit size, room temperature, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs testosterone cypionate, 200 mg/mL, 6 mL and 10 mL unit sizes, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs testosterone cypionate, 100 mg/mL, 10 mL unit size, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Drugs papaverine phent, 25 mg/0.833 mg/mL, 20 mL unit size Refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 All lots Class II Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. Abbott's Compounding Pharmacy, Inc.
Devices Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model number: H48; Product Usage: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. Model: H48: Serial numbers: H480110 H48C045 H488552 H480119 H487642 H480345 H480409 H480541 H480814 H48D577 H481205 H48D125 H48I971 H488466 H48A830 H48G592 H48L819 H480267 H48C046 H488553 H480123 H48B153 H480348 H489828 H480542 H480819 H48D580 H481206 H48D126 H48I972 H489917 H48K547 H48G593 H48L823 H480268 H48K563 H48I901 H480124 H48B154 H480349 H48E077 H480566 H480820 H48I607 H481262 H48E255  ...
More
Class II When using PBC 11.0.31 to calculate the dose for a conventional arc field with more than 100 segments for Eclipse versions 11.0, 13.0, 13.5 or 13.6, the displayed dose does not correspond to the calculated Monitor Units (MU). Potential for unintended radiation exposure. Varian Medical Systems, Inc.
Devices Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product Usage: An accessory for the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations. The Jadak Barcode Scanner is used to scan medication labels during refill of the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations and dispensing medication for patients. 14488129 14488133 14488134 14463683 14463684 14463687 14463688 14463689 14463690 14463691 14463692 14463693 14463694 14463695 14463696 14463697 14463698 14463700 14463701 14463702 14463703 14463704 14463707 14463708 14463709 14463710 14463711 14463712 14463713 14463714 14463715 14463716 14463717 14467646 14467647 14513579 13941887 13941888 13941889 13941890 13941891 13941892 13941893 13941894 13941895 13941896 13941897 13941898 13941899 13943819  ...
More
Class II Customers reported issues when scanning medications with the scanners. When a user scans a medication using the affected barcode scanner, information on a different medication could be communicated to the Pyxis product. CareFusion 303, Inc.
Food Pint Umpqua Dairy Cultured Sour Cream, Item no. 03654, net w. 16 oz.; UPC 0 71203 00403 4. Half Pint Umpqua Dairy Cultured Sour Cream, Item no. 03751, net w. 18 oz.; UPC 0 71203 00401 0. Sell by 2/5/16 Class II Sour cream was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test. Umpqua Dairy Products Co
Food Umpqua French Vanilla Ice Cream, Item no. 12750, 1.75 Quart container, UPC 0 71203 08751 8 Sell by 12/15/16 Class II Umpqua French Vanilla Ice Cream was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test. Umpqua Dairy Products Co
Food Umpqua Birthday Cake Ice Cream, Item no. 12815, 1.75 quart container, UPC 0 71203 08793 8 Sell by 12/15/16 Class II Umpqua Birthday Cake Ice Cream was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test. Umpqua Dairy Products Co
Food Umpqua Mountain Blackberry Revel Ice Cream, Item no. 12823, 1.75 quart container, UPC 0 71203 08758 7 Sell by 12/15/16 Class II Umpqua Mountain Blackberry Revel Ice Cream was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test. Umpqua Dairy Products Co
Food Umpqua Peppermint Candy Ice Cream, Item no. 12904, 1.75 quart container, UPC 0 71203 08793 8 Sell by 12/15/16 Class II Umpqua Peppermint Candy Ice Cream was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test. Umpqua Dairy Products Co
Food Umpqua Peppermint Candy Ice Cream, Item no. 11150, 3 Gallon container, UPC 0 71203 08645 0 15-349 (production date) Class II Umpqua Peppermint Candy Ice Cream was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test. Umpqua Dairy Products Co
Food Umpqua Lowfat Vanilla Soft Serve Ice Cream Mix 4% (Red), item no. 04952, Half gallon container. UPC 0 71203 00494 2. Sell by 1/9/16 Class II Umpqua Lowfat Vanilla Soft Serve Ice Cream Mix 4% (Red) was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test. Umpqua Dairy Products Co
Food Dairy Queen Vanilla Soft Serve Mix, item no. 04960, 5 gallon container. UPC 0 71203 00489 8 010716 and 010816 Class II Dairy Queen Vanilla Soft Serve Mix was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test. Umpqua Dairy Products Co
Food Dairy Queen Chocolate Soft Serve Mix, item no. 04979, 5 gallon container. UPC 0071203004874 010816 Class II Dairy Queen Chocolate Soft Serve Mix was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test. Umpqua Dairy Products Co
Food Umpqua Vanilla Ice Cream, item no. 09997, 3 gallon container. UPC 0 71203 08620 7 15-348 (production date) Class II Umpqua Vanilla Ice Cream was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test. Umpqua Dairy Products Co
Food Sunshine Empress Vanilla Ice Cream, item no. 12175, 3 gallon container. No UPC code. 15-348 (production date) Class II Sunshine Empress Vanilla Ice Cream was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test. Umpqua Dairy Products Co
Food Pint Umpqua Dairy 4% Cottage Cheese, item no. 04308, Net wt. 16 oz. UPC 0 71203 00248 1 24 oz. Umpqua Dairy 4% Cottage Cheese, item no. 04286, UPC 0 71203 00255 9. 3 lbs. Umpqua Dairy 4% Cottage Cheese, item no. 03980, UPC 0 71203 00280 1. Sell by 1/13/16 Class II Umpqua Dairy 4% Cottage Cheese was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test. Umpqua Dairy Products Co
Food Pint Umpqua Dairy 1.5% Lowfat Cottage Cheese, item no. 04839, net wt. 16 oz. UPC 0 71203 00360 0. 3 lbs. Umpqua Dairy 1.5% Lowfat Cottage Cheese, item no. 04146, net wt. 3 lbs.. UPC 0 71203 00376 1. sell by 1/13/16 Class II Umpqua Dairy 1.5% Lowfat Cottage Cheesewas made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test. Umpqua Dairy Products Co
Food Pint Umpqua Dairy Nonfat Cottage Cheese, item no. 04847, Net wt. 16 oz., UPC 0 71203 00373 0 Sell by 1/13/16 Class II Umpqua Dairy Nonfat Cottage Cheese was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test. Umpqua Dairy Products Co
Biologics Apheresis Platelets, Leukocytes Reduced W158015703019 (double collection) Class III Platelet products, labeled with the incorrect volume, were distributed. ARUP Laboratories, Inc.
Biologics Apheresis Fresh Frozen Plasma W035815162565 Class III Misbranded apheresis product was distributed. BloodSource, Inc.
Devices MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifiers) Electromyography. (EMG) Serial Numbers: MS-110B: (17 units) 00013-00019, 00023- 00032 MS-120BK: (6 units) 0009- 00014 JB-116B: (31 units), 0008, 00012, 00014, 00016, 00018, 00019, 00020, 00021, 00023, 00025, 00026, 00027, 00028, 00029, 00031, 00032, 00034, 00035, 00039, 00043, 00102,00103, 00122-00128, 00134, 00135 JB-132B: (83 units) 00009, 00011, 00012, 00014, 00015, 00016, 00018, 00019, 00020, 00021, 00023,  ...
More
Class II The MEE-1000A Neuromaster had defective printed circuit boards (PCBs). Gas arrestors on these boards which were intended to provide protection from electrostatic discharge failed to prohibit unintentional current flow. Nihon Kohden America Inc
Devices CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. Description  Carcinoembryonic antigen (CEA), is synthesized during development in the fetal gut, and is re-expressed in increased amounts in intestinal carcinomas and several other tumors. Antibody to CEA is reportedly useful in identifying the origin of various metastatic adenocarcinomas and in distinguishing pulmonary adenocarcinomas (60-70% are CEA+) from pleural mesotheliomas (rarely or weakly CEA+). This product is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin-embedded tissue sections, to be viewed by light microscopy. Product Code: RB-368-R7; RB368-R1, Lot Number 368R1407A 368R1407C 368R1407D 368R1407E, all with expiry dates of July 2016. Product code: RB368-R1, Lot Number 368R1407B. Class III Certain lots of CEA/CD66e Ab2 were produced with a dilution factor of 1:100 instead of the recommended 1:250. Lab Vision Corporation
Biologics Cornea CH131170OS Class II Human Cornea, recovered in a manner that may have caused contamination or cross-contamination otherwise increasing the risk of the introduction, transmission, or spread of communicable disease, was distributed. Saving Sight
Biologics Apheresis Platelets, Leukocytes Reduced W200215813755 Class II Apheresis product, lacking assurance of proper leukoreduction, was distributed. American Red Cross Blood Services
Devices LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6 LT-LAT / RT-MDL; Tibial knee prosthesis, augment. 14KM16422 Class II The package for catalog item, a LEGION Hemi Stepped Tibial Wedge, 5 MM Size 5-6 LT-LAT/ RT-MDL, should include both a screw-on hemi stepped tibial wedge and two tibial wedge screws to affix the wedge to the tibial baseplate. A complaint was received indicating that the screws packaged with the wedge were too long. Smith & Nephew, Inc.
Drugs Menthocin Patch with Lidocaine-Strong (Menthol 5%, Capsaicin 0.0375%, Methyl Salicylate 20%, Lidocaine 0.5%), packaged in a box 15 patches, RX Only, Manufactured for Bonita Pharmaceuticals LLC 6380 Commerce Drive Westland, MI 48185-9120, USA NDC 53598-0012-15 Lot#: 20150326, Exp 03/2018 Class II Marketed without an approved NDA/ANDA Bonita Pharmaceuticals, LLC
Devices Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Product is packed in a sealed pouch, ten (10) pouches per case. Cardiopulmonary bypass catheter. lot - 1529300018 Class II Sorin Group initiated field correction for the Dual Stage Venous Return Catheter because the incorrect Instructions For Use (IFU) was packaged in the case. Sorin Group USA, Inc.
Biologics Red Blood Cells, Leukocytes Reduced W224311322421 Class II Blood product, collected from a donor who received a tattoo within one year of donation, was distributed. Houchin Community Blood bank
Biologics Apheresis Platelets, Leukocytes Reduced W069115150701A; W069115150701B; W069115150701C Class II Apheresis products, in which leuko reduced units did not meet WBC count specification, were distributed. Mississippi Blood Services Inc.
Biologics Blood and Blood Products for Reprocessing W204015192537 Class III Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. American Red Cross Blood Services Heart of America Region
Biologics Platelets, Irradiated W230815237939 Class II Platelet product, collected from a duplicate donor who was previously deferred due to CJD travel risk, was distributed. Coastal Bend Blood Center
Biologics Source Plasma 15NTNC8178; 15NTNC7728; 15NTNC7035; 15NTNC7279; 15NTNC5220; 15NTNC5149; 15NTNC5657; 15NTNC4406 Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Plasma Biological Services, Inc
Biologics Source Plasma 15NTNC9150; 15NTNC8476; 15NTNC8106; 15NTNC6848; 15NTNC7416; 15NTNC5817; 15NTNC5438; 15NTNC4895; 15NTNC3845; 15NTNC3130; 15NTNC2385; 15NTNC2036; 15NTNB8321 Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Plasma Biological Services, Inc
Food Little Temptations Sour Strawberries Net Wt. 7.5 oz (213g) Packed by: Crystal Temptations, North Arlington, NJ 07031 UPC 611190469401 BB JUNE 15 2016 C 223 1504 Class II Sour strawberries contain undeclared FD&C Blue #1 and Yellow #5. JNC International Inc.
Biologics Rh Immune Globulin (Human) RVP241B1 Class III Misbranded Rho(D) Immune Globulin (Human) was distributed. Kedrion Melville Inc.
Drugs TEARS Naturale FREE (dextran 70 and hypromellose 2910) lubricant eye drops, 1% and 0.3%, Preservative Free, 0.9 mL (0.03 FL OZ) Single-Use Vials, packaged in 60-count Single-Use Vials per carton, Manufactured for: Alcon Laboratories, Inc., Fort Work, TX 76134, Barcode 90016741106, UPC 3 00650 41636 8. Lot #: KRJ006, Exp 09/17 Class II Lack of Assurance of Sterility: Some single-use vials may be filled with water rather than the product solution and the firm cannot guarantee the sterility of the water-filled vials. Alcon Research, Ltd.
Show all Code Info
-
-