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U.S. Department of Health and Human Services

Enforcement Report - Week of November 12, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Devices Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is a Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solutions at a 4:1 ratio. In includes a Conducer Heat Exchanger and a Bubble Trap module. Additionally, the set is constructed with a female luer connector that is the subject of the correction/removal activity Item Number: 58520-Lot Numbers: MF24, MM11, MN01. Manufacturing dates May 24, 20 I 0 through November I, 2010 Item Number: 1610-Lot Numbers: MM11, MN08, MNI5, MN29 MP07. Manufacturing dates October 11, 20 I 0 through December 7, 20 I 0 Class II Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line Terumo Cardiovascular Systems Corp
Devices Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: 16110 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets - and includes the female luer connector that is the subject of this correction/removal activity Lot Numbers: ML13, MM04. Manufacturing datese September 13, 2010 through October 4, 20 I 0. Class II Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line Terumo Cardiovascular Systems Corp
Devices Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery. Lot Numbers: MN08, MNI5, MM11, MM18, MM25. Manufacturing dates October 1I, 2010 through Novemberl5, 20 I 0. Class II Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line Terumo Cardiovascular Systems Corp
Devices Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kits with a 5-digit code beginning with the digit 6: Catalog Number: 6XXXX ; Catalog Codes: Kits with a 5-digit code beginning with the digit 7: Catalog Number: 7XXXX Product usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. Catalog Number: 6XXXX Lot Numbers: ML07, MM18, MM25, MN08, MN IS, MN22. Manufacturing dates September 7, 20 I 0 through November 22, 20 I 0. Catalog Number: 7XXXX Lot Numbers: ML07,ML20, MM18, MM25, MNO1, MN08, MN15, MN29,MP06, MP13. Manufacturing dates September 7, 2010 through December 13,2010. Class II Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line. Terumo Cardiovascular Systems Corp
Devices Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 Product Usage: Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solutions at a 4: I ratio. Includes a Conducer Heat Exchanger and a MP4 Temperature & Pressure Module. Additionally, the set is constructed with a female luer connector that is the subject of the correction/removal activity. Catalog Number: 165720 Lot Numbers: MDI5, MD15B, MD22, ME19, MP13. Manufacturing dates March 15, 20 I 0 through December 13, 20 I 0. Catalog Number: 6375 Lot Numbers: MD15, ME19, MPI3 Manufacturing dates March 15, 2010 through December 13, 20 I 0 Class II Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line Terumo Cardiovascular Systems Corp
Devices Terumo Custom Cardioplegia Delivery Sets Catalog Code: 204880 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets-and includes the female luer connector" that is the subject of this correction/removal activity Lot Numbers: MN08 Manufacturing Date November 8, 20 I 0. Class II Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line Terumo Cardiovascular Systems Corp
Veterinary Eukanuba Dog Food Base Large Breed Mature Adult, 15 lb. (UPC: 19014270156), and 30 lb. (UPC: 19014270309) bags Lot Code: 31874177, Best by Date: 6Nov14. Class I Product has the potential to be contaminated with Salmonella. Procter & Gamble Co
Veterinary Eukanuba Dog Food Base Maintenance Mature Adult, 30 lb bag, UPC: 19014149308 Lot Code: 31954177, Best by Date: 14Nov14. Class I Product has the potential to be contaminated with Salmonella. Procter & Gamble Co
Veterinary Eukanuba Dog Food Base Small Breed Adult, 4 lb (UPC: 19014039722) and 16 lb (UPC: 19014010516) bags Lot Code: 31904177, Best by Date: 9Nov14. Class I Product has the potential to be contaminated with Salmonella. Procter & Gamble Co
Veterinary Eukanuba Dog Food Breed Specific Chihuahua Adult, 4 lb bags, UPC: 19014607037 Lot Code: 31884177, Best by Date: 7Nov14. Class I Product has the potential to be contaminated with Salmonella. Procter & Gamble Co
Veterinary Eukanuba Dog Food Breed Specific Labrador Retriever Adult, 36 lb bags, UPC: 19014019564 Lot Code: 31954177, Best by Date: 14Nov14. Class I Product has the potential to be contaminated with Salmonella. Procter & Gamble Co
Veterinary Eukanuba Dog Food Premium Performance 30/20 Adult, 33 lb bags, UPC: 19014609475 Lot Code: 31884177, Best by Date: 7Nov14. Class I Product has the potential to be contaminated with Salmonella. Procter & Gamble Co
Veterinary Eukanuba Dog Food Professional Feeding Bag Small Breed Puppy, 44 lb bags, UPC: 19014113194 Lot Code: 31874177, Best by Date: 6Nov14. Class I Product has the potential to be contaminated with Salmonella. Procter & Gamble Co
Veterinary Eukanuba Dog Food Weight Control Large Breed Adult, 30 lb bags, UPC: 19014269303 Lot Code: 31894177, Best by Date: 8Nov14, Lot Code: 31924177, Best by Date: 11Nov14. Class I Product has the potential to be contaminated with Salmonella. Procter & Gamble Co
Veterinary Iams Dog Food Healthy Naturals Chicken Adult, 2.9 lb (UPC: 19014700165), 5 lb (UPC: 19014612635), 13.3 lb (UPC: 19014612017) and 25.7 lb bags (UPC: 19014700646) Lot Code: 31944177, Best by Date: 13Nov14 (2.9 lb.); Lot Code: 31904177,  ...
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Class I Product has the potential to be contaminated with Salmonella. Procter & Gamble Co
Veterinary Iams Dog Food Healthy Naturals Weight Control Adult, 13.3 lb bags, UPC: 19014612024 Lot Code: 31894177, Best by Date: 8Nov14 Class I Product has the potential to be contaminated with Salmonella. Procter & Gamble Co
Veterinary Iams Dog Food Premium Protection Chicken Adult, 12.1 lb bags, UPC: 19014611362 Lot Code: 31894177, Best by Date: 8Nov14. Class I Product has the potential to be contaminated with Salmonella. Procter & Gamble Co
Veterinary Iams Dog Food ProActive Health Large Breed Senior Plus, 13.3 lb (UPC: 19014612000) and 26.2 lb bags (UPC: 19014700615) Lot Code: 31934177, Best by Date: 12Nov14 (both sizes) Class I Product has the potential to be contaminated with Salmonella. Procter & Gamble Co
Veterinary Iams Dog Food ProActive Health Large Chunks Adult, 15 lb bags, UPC: 19014610815 Lot Code: 31944177, Best by Date: 13Nov14 Class I Product has the potential to be contaminated with Salmonella. Procter & Gamble Co
Veterinary Iams Dog Food ProActive Health Small Breed Adult, 3.1 lb (UPC: 19014700110), 13.3 lb (UPC: 19014610990) and 5 lb bags (UPC: 19014612055) Lot Code: 31874177, Best by Date: 6Nov14 & Lot Code: 31894177, Best by Date: 8Nov14 (3.1 lb), Lot  ...
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Class I Product has the potential to be contaminated with Salmonella. Procter & Gamble Co
Veterinary Iams Dog Food ProActive Health Small Breed Puppy, 5 lb bags UPC: 19014700943 Lot Code: 31904177, Best by Date: 9Nov14. Class I Product has the potential to be contaminated with Salmonella. Procter & Gamble Co
Veterinary Iams Cat Food Healthy Naturals Chicken Adult, 5 lb (UPC: 19014612697) and 16 lb bags (UPC: 19014611881) Lot Code: 31874177, Best by Date: 6Nov14 & Lot Code: 31944177, Best by Date: 13Nov14 (5 lb) and Lot Code: 31874177, Best by Date: 6Nov14 & Lot Code: 31944177, Best by Date: 13Nov14 (16 lb). Class I Product has the potential to be contaminated with Salmonella. Procter & Gamble Co
Veterinary Iams Cat Food Healthy Naturals Weight Control Adult, 5 lb bags, UPC: 19014612703 Lot Code: 31894177, Best by Date: 8Nov14. Class I Product has the potential to be contaminated with Salmonella. Procter & Gamble Co
Veterinary Iams Cat Food ProActive Health Chicken Adult, 3.2 lb (UPC: 19014612659), 5.7 lb (UPC: 19014612499), 6.3 lb (UPC: 19014611621), 10.8 lb (UPC: 19014612086) and 17.4 lb bags (UPC: 19014611836) Lot Code: 31904177, Best by Date: 9Nov14; Lot Code: 31924177, Best by  ...
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Class I Product has the potential to be contaminated with Salmonella. Procter & Gamble Co
Veterinary Iams Cat Food ProActive Health Chicken Kitten, 3.2 lb (UPC: 19014612628), 5.7 lb (UPC: 19014612505), 17.4 lb bags (UPC: 19014611867) Lot Code: 31904177, Best by Date: 9Nov14 & Lot Code: 31954177, Best by Date: 14Nov14 (3.2 lb) & Lot Code: 31904177, Best by Date: 9Nov14 and Lot Code: 31954177, Best By Date: 14Nov14 (5.7 lb) and Lot Code: 31904177, Best by Date: 9Nov14 (17.4 lb). Class I Product has the potential to be contaminated with Salmonella. Procter & Gamble Co
Veterinary Iams Cat Food ProActive Health Digestive Care Adult, 3 lb (UPC: 19014700202), 5 lb (UPC: 19014612451) and 16 lb bags (UPC: 19014611904) Lot Code: 31904177, Best by Date: 9Nov14 & Lot Code: 31954177, Best by Date: 14Nov14 (3 lb); Lot Code: 31904177, Best by Date: 9Nov14 & Lot Code: 31954177, Best by Date: 14Nov14 (5 lb) and Lot Code: 31904177, Best by Date: 9Nov14 and Lot Code: 31954177, Best by Date: 14Nov14  ...
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Class I Product has the potential to be contaminated with Salmonella. Procter & Gamble Co
Veterinary Iams Cat Food ProActive Health Hairball Adult, 3.1 lb (UPC: 19014700219), 5 lb (UPC: 19014612420), 9.8 lb (UPC: 19014612161) and 16 lb bags (UPC: 19014611911) Lot Code: 31884177, Best by Date: 7Nov14, Lot Code: 31914177, Best by  ...
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Class I Product has the potential to be contaminated with Salmonella. Procter & Gamble Co
Veterinary Iams Cat Food ProActive Health Hairball Mature Adult, 5 lb bags, UPC: 19014612604 Lot Code: 31954177, Best by Date: 14Nov14. Class I Product has the potential to be contaminated with Salmonella. Procter & Gamble Co
Veterinary Iams Cat Food ProActive Health Weight Control & Hairball Adult, 2.9 lb, (UPCs: 19014700240 and 19014700257), 5 lb (UPC: 19014612789), 5.5 lb (UPC: 19014611652), 9.8 lb (UPC: 19014612130) and 16 lb bags (UPC: 19014612147) Lot Code: 31914177, Best by Date: 10Nov14, Lot Code: 31924177, Best by  ...
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Class I Product has the potential to be contaminated with Salmonella. Procter & Gamble Co
Veterinary Iams Cat Food ProActive Health Weight Control Adult, 5 lb (UPC: 19014612680), 9.8 lb (UPC: 19014612123) and 16 lb bags (UPC: 19014612178) Lot Code: 31874177, Best by Date: 6Nov14, Lot Code: 31934177, Best by Date: 12Nov14 (5 lbs); Lot Code: 31874177, Best by Date: 6Nov14 (9.8 lbs) and Lot Code: 31874177, Best by Date: 6Nov14 & Lot Code: 31934177, Best by Date: 12Nov14 (16 lbs). Class I Product has the potential to be contaminated with Salmonella. Procter & Gamble Co
Veterinary Iams Cat Food Professional Feeding Bag Chicken Adult, 33 lb bags, UPC: 19014105458 Lot Code: 31914177, Best by Date: 10Nov14 and Lot Code: 31944177, Best by Date: 13Nov14. Class I Product has the potential to be contaminated with Salmonella. Procter & Gamble Co
Veterinary Eukanuba Dog Food Base Maintenance Puppy, 5 lb. (UPC 19014039852), 16.5 lb. (UPC 19014042234), and 33 lb. (UPC 19014609468) bags Lot Code: 31884177, Best by Date: 7Nov14 Class I Product has the potential to be contaminated with Salmonella. Procter & Gamble Co
Veterinary Eukanuba Dog Food Base Small Breed Puppy, 4 lb. (UPC 19014039678), 16 lb. (UPC 19014010509), and 40 lb. (UPC 19014011070) bags Lot Code: 31874177, Best by Date: 6Nov14 (4 lb); Lot Code: 31944177, Best by Date 13Nov14 (16 lb) and Lot Code: 31874177, Best by Date 6Nov14 & Lot Code: 31944177, Best by Date 13Nov14 (40 lb). Class I Product has the potential to be contaminated with Salmonella. Procter & Gamble Co
Veterinary Eukanuba Dog Food Breed Specific Boxer Adult, 36 lb. bags (UPC 19014019588) Lot Code: 31944177, Best by Date: 13Nov14 and Lot Code: 31954177, Best by Date 14Nov14 . Class I Product has the potential to be contaminated with Salmonella. Procter & Gamble Co
Veterinary Iams Dog Food ProActive Health Large Breed Mature Adult, 30 lb. bags (UPC 19014611331) Lot Code: 31884177, Best by Date: 7Nov14. Class I Product has the potential to be contaminated with Salmonella. Procter & Gamble Co
Food KFI SWEETENED GINGER CANDY (Mut Gung), NET WEIGHT: 8.8 oz (250 g) - PRODUCT OF VIETNAM - UPC 8 935001 201304 -- Distributed by: K-FAT INC. 13 MEADOW STREET, BROOKLYN, NY 11206, USA TEL: 718-381-0306 FAX: 718-381-0089 --- The product is packed in a clear, hard plastic container. UPC 8 935001 201304 and no other coding Class I The product was found to contain undeclared sulfites (268.8 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets. K-Fat Inc.
Food GRANDMA'S perogies POTATO & BACON PEROGIES, NET WEIGHT 907 g (32 oz/2 lb), UPC 8 92691 00112 7. Product packed in plastic bag with pink label and contains 14 - 2 lb bags per case. Manufactured by S&A Grandma's Food Inc. 196-44 Fasken Drive Toronto, ON M9W 5M8 (416) 679-8444, www.grandmafoods.com. Product of Canada. expiration date 040414 to 040415 Class I Buffalo SAV, Inc. has recalled GRANDMA'S perogies POTATO & BACON PEROGIES due to the presence of Undeclared Soy. BUFFALO SAV, INC.
Biologics Source Plasma 04205025690, 04205042588, 04205058934, 04204507128, 04204764730, 04204667447, 04204782517, 04204188163, 04204253447, 04204886543, 04204899070, 04204917629, 04204995694, 04205118087, 04205150060, 04205126845, 04205244163, 04205246302, 04204664836, 04204838584, 04204904203, 04204931359, 04204957516, 04205017024, 04205035249, 04205108524, 04205198320, 04204581774, 04204600920, 04204750742, 04204761054, 04204797460, 04205047426, 04204186694, 04204255848, 04204294960, 04204316209, 04204340268, 04204375209, 04204511426, 04204801773, 04204822603, 04204840545, 04205034182, 04205057000, 04204914145, 04205089394, 04204142579, 04204166781, 04204907666,  ...
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Class II Source Plasma units, collected from ineligible donors, were distributed. CSL Plasma, Inc.
Devices Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35% ProClin 950 as a preservative. Total volume = 7 mL. This reagent is for in vitro diagnostic use. Thyroglobulin (1D4) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of thyroglobulin in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using an automated Bond system. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist. Product Code: PA0025; Lot Numbers and Expiration Dates: 24963, Expires 17 DEC 2014; 24228, Expires 15 OCT 2014; 23882, Expires 10 SEP 2014; 23366, Expires 23 JUL 2014 Class II Bond Ready to Use Primary Antibody Thyroglobulin does not function as intended up to the expiry date on the product labelling. This was detected through an on-going stability program. There is a link between the age of the product and staining intensity. Leica Microsystems, Inc.
Food Carob Supergreens Chunks of Energy (10# UPC 7-69270-10009-7); also, Carob Supergreens Chunks of Energy and Rave BItes Brand Carob Supergreens (7 oz UPC 7-69270-70008-8). Production lots 10 lb: (0844-1, 0844-2, 0844-3, 0954-1, 0954-2, 0954-3, 0954-4, 0994-1, 0994-2, 1014, 1094-1, 1094-2, 1094-3, 1154-1, 1154-2, 1154-3, 1154-4, 1574, 1634-1,1634-2, 1634-3, 1644, 1684, 1744-1, 1744-2, 1744-3, 1824-1, 1824-2, 1924-1, 1924-2, 1994). Production Lot, 7 oz: 1014.; Rave Bites Carob Supergreens, 7 oz. Sell By Date 6/06/15. Class I Product may be contaminated with Salmonella. Dancing Star LLC
Food Date Flax with Turmeric Chunks of Energy (10# UPC 7-69270-20004-5); also Date Flax Turmeric Chunks of Energy and Rave Bites Date Flax with Turmeric (7 oz UPC 7-69270-70006-4). Production Lots: 10-lb (0794-1, 0794-2, 0794-3, 0954, 1004, 1084, 1124, 1134-1, 1134-2, 1134-3, 1134-4, 1134-5, 1624-3, 1784-1, 1914, 1974); Production Lot: 7 oz 1004; Rave Bites Date Flax with Turmeric (7oz Sell By Dates 4/10/15 and 4/25/15) Class I Product may be contaminated with Salmonella. Dancing Star LLC
Food Bulk organic Carob powder (10# UPC 7-69270-80001-6) Julian dates (0154, 0914, 0974, 0994, 1044, 1054, 1114, 1154, 1194, 1534, 1684, 1704, 1824, 1894) Class I Product may be contaminated with Salmonella. Dancing Star LLC
Devices Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Accessories. The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures. Product code: 2B8011 Lot Number: UR13D15112 Class I Particulate matter found inside the fluid path. Baxter Healthcare Corp
Devices Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml. Admixture Products and Accessories The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures. Product code 2B8013 Lot Number: UR13K14095 Class I Particulate matter found inside the fluid path. Baxter Healthcare Corp
Biologics Red Blood Cells Leukocytes Reduced W071214032790; W071214032803; W071214031297; W071214032735; W071214031008; W071214031689; W071214031038; W071214031636; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Medic Inc
Biologics Invitrogen by Life Technologies, DPB1 SSP UniTray, DPB1 SSP UniTray with Taq, AllSet Gold DPB1 High Res SSP. Catalog # (SKU) Product Name Lot/Serial Number 210101 (AMBISOLV TUBE FORMAT 40 TESTS): 134487 451606D (DPB1 SSP UNITRAY 12 TESTS): 0081190373, 0081220578, 0081289713, 0091415057, 0091464121, 0091568516 451616D (DPB1 SSP UNITRAY W/TAQ 12 TEST): 0081154360, 0081190373, 0081220578, 0081289713, 0091415057, 0091464121 54070D (ALLSET GOLD DPB1 HIGH RES SSP): 0081204422, 0081256851, 0091377591, 0091450550, 0091544263 Class III HLA typing assay, associated with false negative results, were distributed. Life Technologies Corporation
Biologics Red Blood Cells Leukocytes Reduced W037713060158; Class III Blood products, collected from a donor who was at risk for leishmaniasis, were distributed. Hoxworth Blood Center
Biologics Platelets Pooled Leukocytes Reduced W037713506167; Class III Blood products, collected from a donor who was at risk for leishmaniasis, were distributed. Hoxworth Blood Center
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W037714001547; W037714001547; W037713024767; W037713024767; Class III Blood products, collected from a donor who was at risk for leishmaniasis, were distributed. Hoxworth Blood Center
Devices Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovation Prime Abdominal Stent Graft System is a low-profile endovascular device delivered via catheter to treat descending abdominal aortic aneurysms (AAAs). The devices subject to this action are labeled for distribution outside of the United States; therefore, no UDI is on the device label or package. Model Number: TV-AB2980-D Lot Numbers: FS031814-11 FS052214-22 FS052814-36 FS040414-21 FS050614-56 FS040714-53 FS040514-02 FS042614-05 FS050614-53 FS032614-46 FS050214-27 FS050314-12 FS052214-48 FS052214-53 FS031814-44 FS031814-49 FS032714-04 FS032714-20 FS040414-30 FS040514-08 FS050114-01 FS050114-08 FS050514-18 FS050514-27 FS050614-54 FS050614-55 FS051914-32 FS051914-34 Expiry dates ranging "May-17" through "Jun-17" Class I TriVascular has identified select lots of Ovation Prime 29mm Aortic Body stent grafts that may be associated with rapid emptying of the fill polymer syringe when it is connected to the Autoinjector during the fill polymer injection step of the primary implant procedure. Trivascular, Inc
Devices Prescription eyeglass safety lenses. Vision correction No lot codes are applied. The recalled products contain the following model numbers: LC Elite 1.50 80mm  ...
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Class II Prescription eyeglass safety lenses did not meet specifications. Eyemart Express Ltd
Veterinary Clindamycin hydrochloride oral liquid, 25 mg per mL, in 20-ml. plastic bottles, RX, ANDA #200-291, packaged under the following labels: (1) Virbac Animal Health Clinsol Liquid, NDC 051311-500-25, Mfd. by Virbac AH, Inc., Fort Worth, TX; and (2) VEDCO ClindaCure, NDC 050989-495-09, Mfd. for VEDCO, Inc., St. Joseph, MO. (1) Lot numbers for Clindacure: 130158, 130528, 130840, 130748, 131107, 131353, 131404, 140117, 140229, and 140531; and (2) Lot numbers for Clinsol: 130278, 131107, and 140276. Class III Failing stability specifications at the 18 month time point. Virbac AH, Inc
Drugs Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, 30-count bottles and 90-count bottles, RX only, Manufactured for Sun Pharma Global Inc. Dubai, United Arab Emirates by Sun Pharmaceutical Industries Limited, Halol, India Batch Number: JKM3855A Mfg. Date: 06/25/2013 Exp. Date: 05/31/2015 Batch Number: JKM3855B Mfg. Date: 06/25/2013 Exp. Date: 05/31/2015 Batch Number: JKM7265A Mfg. Date: 12/25/2013 Exp. Date: 11/30/2015 Batch Number: JKM7265B Mfg. Date: 12/25/2013 Exp. Date: 11/30/2015 Class II Failed Dissolution Specification; 12 month stability timepoint Sun Pharma Global Inc.
Biologics Platelets Pheresis Leukocytes Reduced W311214001607; Class II Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed Atlanta Blood Services
Devices Stryker SmartLife Large Aseptic Housing REF 7126-120-000 Rx Only The SmartLife" Aseptic Housings are designed to be used in conjunction with the SmartLife Non-Sterile Batteries to provide power for System 7 Handpieces, Cordless Driver 4 Handpiece, and Sabo2 Sagittal Saw Handpiece. Part Number 7126-120-000; All lot numbers from 13027 to 14093 Class II The SmartLife Aseptic Housings are being recalled in that the top section of the housing may separate from the bottom section due to insufficient welding. Stryker Instruments Div. of Stryker Corporation
Devices Stryker SmartLife Small Aseptic Housing REF 7222-120-000 Rx Only The SmartLife" Aseptic Housings are designed to be used in conjunction with the SmartLife Non-Sterile Batteries to provide power for System 7 Handpieces, Cordless Driver 4 Handpiece, and Sabo2 Sagittal Saw Handpiece. Part Number 7222-120-000; All lot numbers from 13072 to 14121 Class II The SmartLife Aseptic Housings are being recalled in that the top section of the housing may separate from the bottom section due to insufficient welding. Stryker Instruments Div. of Stryker Corporation
Biologics Cornea SD13315OD; Class II Human Cornea, recovered from a donor whose donor eligibility determination failed to assure the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed. South Dakota Lions Eye Bank, Inc
Food Mama Tere Arepa de Chocolo Sweet Corn Patty 10.5 oz/300g 4 units Product of Colombia Importado Por: Family Food Distributors, Inc. 969 Newark Turnpike, Unit D, Kearny, NJ 07032 None. Class II Mama Tere Arepa de Moto, de Chocolo and and de Blanca de Maiz were found to be mislabeled. Family Food Distributors, Inc.
Food Mama Tere Arepa de Blanca de Maiz White Corn Patty 14.1 oz/400g 5 units Product of Colombia Importado Por: Family Food Distributors, Inc. 969 Newark Turnpike, Kearny, NJ 07032 UPC 812828011676 None. Class II Mama Tere Arepa de Moto, de Chocolo and and de Blanca de Maiz were found to be mislabeled. Family Food Distributors, Inc.
Food Mama Tere Arepa de Moto Hominy Patty 14.1 oz / 400 g 5 units Product of Colombia Importado Por: Family Food Distributors, Inc. 969 Newark Turnpike, Kearny, NJ 07032 UPC 812828011652 None. Class II Mama Tere Arepa de Moto, de Chocolo and and de Blanca de Maiz were found to be mislabeled. Family Food Distributors, Inc.
Biologics Red Blood Cells Leukocytes Reduced W035214063997F; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Carter BloodCare
Biologics Fresh Frozen Plasma W035214063997F; Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Carter BloodCare
Devices CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. Product Usage: The CADD-Solis Medication Safety Software- Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD-Solis VIP Ambulatory Infusion Pump, CADD-Solis Ambulatory Infusion Pump, or CADD-Prizm PCSII Ambulatory Infusion Pump (software revision H or higher). The CADD-Solis Medication Safety Software- Point of Care allows use of a computer to send therapy-based protocols developed by the CADD-Solis Medication Safety Software.- Administrator to the CADD -Solis Ambulatory Infusion Pump and CADD-Prizm PCS I I Ambulatory Infusion Pump (software revision H or higher). Lot Number 2752712 Class II Smiths Medical has identified an issue with a single batch (Lot Number 2752712) of CADD"-Solis Medication Safety Software Administrator 3.1 CDs. CADD"-Solis Medication Safety Software Administrator 3.1 CDs were sent with the CADD"-Solis Medication Safety Software Point of Care 3.1 software loaded on them. Smiths Medical ASD, Inc.
Biologics Red Blood Cells Leukocytes Reduced W089813351081; Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Inova Health Care Services, Inova Blood Donor Services
Biologics Red Blood Cells 2137026; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Cryoprecipitated AHF 2137026; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Devices UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade. 89-8507-400-00 - UNIVERSAL Modular Electric/Battery Double Trigger Handpiece 89-8507-400-10 - UNIVERSAL Modular Electric/Battery Single Trigger Handpiece 222805 222806 222807 222808 222809 222810 222811 222812 222813 222814 222945 222946 222947 222948 222949 222950 222951 222952 222953 222955 222956 223077 223078 223079 223080 223081 223082 223083 223084 223085 223086 223199 223200 223201  ...
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Class II Non-injury complaints from Europe identified a malfunction that made it possible for a handpiece to start by itself when the power source is connected. Zimmer Surgical Inc
Devices Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref) 26284A38, 26900A38, 27991A38, 28192A38, 29571A38, 31162A38, 32488A38, 35243AB39, 35295AB39, 36091AB39, 39464AB39, 40245AB39, 41317AB39, 26285A38, 27348A38, 29169A38, 30710A38, 31261A38, 32687A38, 35259AB39, 35359AB39, 36289AB39, 39031AB39, 41124AB39, 27236A38, 35051A38, 35839AB39, 40141AB39, 41702AB39 Class II Positive bias for Calibrator E lot kits ending in 38 and 39 with the ADVIA Centaur Systems Cortisol and Progesterone assays compared to the respective master curves. Siemens Healthcare Diagnostics, Inc
Devices Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 Immunoassay system is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids. Serial No. 504489 502713 503114 503824 504400 504373 501946 507570; 503285, 800337, 700292 505091 509407 509349 509793 509801 509764 509768 509671 509628 509670 509690, 509705 509724 509800 509771 509744 509746, 509735 509668 509799 509626 509797 509669 509765 509790 509798 509739 509736 509769 509287 504104 509063 509256 509511 503600 505722 502105  ...
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Class II Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the Access 2 Immunoassay systems because it may experience a "MFC Exception" error during normal operation of the Access 2 Immunoassay Systems. Beckman Coulter Inc.
Devices UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Use Part No. A93659AB. Product Usage: The DxI 600i systems are in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids. Serial No. 504489 502713 503114 503824 504400 504373 501946 507570; 503285, 800337, 700292 505091 509407 509349 509793 509801 509764 509768 509671 509628 509670 509690, 509705 509724 509800 509771 509744 509746, 509735 509668 509799 509626 509797 509669 509765 509790 509798 509739 509736 509769 509287 504104 509063 509256 509511 503600 505722 502105  ...
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Class II Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the DxC 600i analyzer because it may experience a "MFC Exception" error during normal operation of the analyzer system. Beckman Coulter Inc.
Veterinary Peng/proc/strep/chlor/hyos (penicillin G, procaine, streptomycin sulfate, chlorpheniramine maleate, hyoscyamine sulfate) (vet) injection suspension packaged in an amber glass injectable vial with silver crimp top and sold under the Martin Avenue Pharmacy brand. Lot Number and Expiration Date: 1) Lot 03312014@29, Expires 9/27/2014; 2) Lot 06262014@20, Expires 12/23/2014 Class II Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all in-date compounded sterile preparations. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance. Martin Avenue Pharmacy, Inc.
Veterinary Phenylephrine 1% injectable packaged in an amber glass injectable vial with silver crimp top and sold under the Martin Avenue Pharmacy brand. Lot Number and Expiration Date: 1) Lot 07182014@40, Expires 9/16/2014; 2) Lot 07252014@43, Expires 9/23/2014 Class II Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all in-date compounded sterile preparations. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance. Martin Avenue Pharmacy, Inc.
Veterinary Prednisolone acetate 50 mg/mL injectable packaged in an amber glass injectable vial with silver crimp top and sold under the Martin Avenue Pharmacy brand. Lot Number and Expiration Date: 1) Lot 05082014@23, Expires 11/4/2014 Class II Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all in-date compounded sterile preparations. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance. Martin Avenue Pharmacy, Inc.
Veterinary ""Tri-mix"" 30 mg/3 mg/5 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial with silver crimp top and sold under the Martin Avenue Pharmacy brand. Lot Number and Expiration Date: 1) Lot 07302014@33, Expires 10/28/2014 Class II Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all in-date compounded sterile preparations.The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance. Martin Avenue Pharmacy, Inc.
Veterinary Tacrolimus oil 0.03% opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. Lot Number: 08072014@63, Exp 9/6/2014 Class II Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all in-date compounded sterile preparations. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance. Martin Avenue Pharmacy, Inc.
Devices Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged. Catalog No: 28MC24130ST, Lot H665694, H669824, Exp 2017 and Catalog No: 28MC24150SN, Lot H665696, Exp 7/3112014 Class II Merit Medical Systems, Inc. is voluntarily recalling the Merit Maestro Microcatheter due to a discrepancy between the labeling and the actual configuration of the device in the packaging. These microcatheters were packaged with a 2.8 F distal tip, rather than the labeled 2.4 F. Merit Medical Systems, Inc.
Food Fiesta Breakfast Scramble, Product # 73EN510. Net Weight 11.4 lbs. 24 - 7.60 oz. portions. Keep Frozen. For Institutional Use Only. Production Facility Buddy's Kitchen, Inc., Burnsville, MN 55337 Production Dates: 07/18/14 and 08/14/14 Class II An ingredient, Tid-bit Potato, tested positive for Listeria monocytogenes. The Tid-Bit Potatoes is an ingredient in Fiesta Breakfast Scramble Buddy's Kitchen, Inc.
Devices Straumann Bone Level Implant 04.1 mm RC, SLActive® 8mm, Roxolid®, Loxim Article Number: 021.4308 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used Lot number: GY256 Class II Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC) Straumann USA, LLC
Devices Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone basket is a teardrop-shaped basket with the ability to capture stones by, opening and closing the basket and articulating or moving the basket from side to side. The device consists of 3 main parts; handle, shaft and basket. It is intended to use in the endoscopic removal of renal and ureteral stones. Product code: 042316, Lot number: BMXJM031 Class II The product is non-sterile. C.R. Bard, Inc.
Devices Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System All Serial numbers Class II If the laser system is turned on and the user adjusts, installs or removes the XPL pulsed light handpiece, there is a potential risk of an electrical shock Cynosure, Inc.
Drugs TORISEL Kit (temsirolimus) injection, 25 mg/mL, 1 vial of TORISEL 25 mg/mL and 1 vial of 2.2 mL DILUENT per carton, Rx only, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA 19101; Diluent  MADE IN ITALY; NDC 0008-1179-01. Kit Lot #: AIEM/13, Exp 05/16 that contain diluent lots AHZW/11 and AHZW/12 Class III Crystallization: Impurities in a raw material used to manufacture the diluent can cause the formation of crystals in the diluent vials after cold storage. The TORISEL vials are not affected by this issue. Pfizer Inc.
Food Saba Shark Cartilage Complex Dietary Supplement, 500 mg, 60 Capsules, Distributed by Saba 711 NE 39th Street, Oklahoma City, OK 73105 Lot number 416349, 08/16 Class I The product is being recalled due to the potential presence of Salmonella. AMS Health Sciences
Devices St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353 Batch # 4671318 Class II St. Jude Medical is performing a voluntary recall of batch 4671318, model number 401353 of the Response Fixed Curve DECA 6F 65cm CSL 2/8 Catheter. Specifically, the firm has identified that every device packaged within batch 4671318 contains the incorrect catheter (Supreme FC QUAD 5F catheter) within the packaging. To date, no serious injuries have occurred as a result of this issue St Jude Medical
Food The Market Basket Asian 7 Rice Cracker Mix Net Wt. 12 oz. (340 g) Distributed by Demondas Supermarkets, Inc. Tewksbury, MA 01876 UPC # 04970540898 Lot# 14248 Class II A peanut fragment was discovered in a carton of 22lb. Asian 7 Rice Cracker Mix. United Natural Trading
Food Asian 7 Rice Cracker Mix in Bulk 22 lb. cases; Wood Stock Farms Lot # YOUI03 sold to Publix Bakery Plant in Lakeland, FL, and to The Nutman Company - USA Inc., in Hubertus, WI. Lot# YOUI03 Class II A peanut fragment was discovered in a carton of 22lb. Asian 7 Rice Cracker Mix. United Natural Trading
Drugs ALPROSTADIL, 10 mcg/mL, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070. Lot #: 20140913@10, discard date 10/28/2014 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs ALPROSTADIL/LIDOCAINE HCL, 20mcg/5mg/mL, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070. Lot #: 20140902@17/1.25; discard date: 10/17/2014 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs ASCORBIC ACID (B), 500 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070. Lot #: 20140821@17, discard date:10/20/2014 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs ASCORBIC ACID (with Preservative), 500 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070. Lot #: 20140827@34, discard date: 10/26/2014; Lot #: 20140909@22, discard dae: 11/8/2014; Lot #: 20140912@2, discard date: 11/11/2014. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs AVASTIN, 1.25mg/0.5mL, injectable, 0.05 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070. Lot #: 20140715@13, discard date: 11/3/2014; Lot #: 20140716@25, discard date: 10/14/2014; Lot #: 20140717@7, discard date: 10/15/2014; Lot #: 20140724@14, discard date: 10/22/2014; Lot #: 20140724@15, discard date: 10/22/2014; Lot #: 20140729@11, discard date: 10/27/2014; Lot #: 20140801@17, discard date: 10/30/2014; Lot #: 20140805@1, discard date: 11/3/2014; Lot #: 20140807@13, discard date: 11/5/2014; Lot #: 20140811@30, discard date:  ...
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Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs BEVACIZUMAB/DEXAMETHASONE, 1.25/0.5 mL, Injectable, 0.05 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070. Lot #: 20140916@3, discard date: 12/15/2014. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs CALCIUM CHLORIDE (COMPOUND), 100 mg/mL, Injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140815@47, discard date: 1/28/2015 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs CEFTAZIDIME, 2.25mg/0.1mL, Injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140905@33, discard date: 10/20/2014 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs CHORIONIC GONADOTROPIN, 4000 Units, sterile powder for reconstitution, glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140728@55, discard date: 1/14/2015; Lot #: 20140915@14, discard date: 3/8/2015. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs CHORIONIC GONADOTROPIN, 5000 Units, sterile powder for reconstitution, glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140909@5, discard date: 3/8/2015; Lot #: 20140728@57, discard date: 1/14/2015. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs CITRIC ACID/GLUCONOLACTONE MAGNES CARB (RENACIDIN), 66/1.98/31.77 mg/mL, solution for irrigation, 30 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140908@2, discard date: 10/23/2014 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs COPPER (SULF), 0.4 mg/mL, injectable, 20 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140919@21, discard date: 11/3/2014 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs DEXAMETHASONE (AS SOD PHOS), 24 mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140903@10, discard date: 10/18/2014 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs DEXPANTHENOL with preservative, 250 mg/mL, injectable, 30 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140828@14; discard date: 11/26/2014 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs DMPS-preservative free, 50 mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140724@24/5, discard date: 10/22/2014; Lot #: 20140724@25, discard date: 10/22/2014; Lot #: 20140826@12, discard date: 11/24/2014. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs EPINEPHRINE/WATER, preservative free 1:1000, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140913@2, discard date: 10/18/2014 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs ESTRADIOL CYPIONATE (COMPOUNDED/GRAPESEED OIL), 5 mg/mL, injectable, 1 ml glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140828@15, discard date: 10/12/2014 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs GANCICLOVIR -preservative free, 2mg/0.1mL, injectable, 0.1 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140916@16, discard date: 10/31/2014 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs GANCICLOVIR, preservative free, 0.2mg/0.05mL, injectable, 0.1 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140911@9, discard date: 10/26/2014 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs GENTAMICIN SULFATE, 100mg/1000mL, solution for irrigation, 400 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140917@27, discard date: 10/22/2014 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs GENTAMICIN SULFATE, 480mg/1000mL, solution for irrigation, 300 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140912@29/150, discard date: 10/16/2014 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs GLUTARALDEHYDE BUFFERED (POTASSIUM PHOSPHATE), solution for irrigation, 250 mL glass bottle, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140722@5, discard date: 10/20/2014; Lot #: 20140723@45, discard date: 10/21/2014. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs GLUTATHIONE with preservative, 100mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140721@25/00, discard date: 11/18/2014; Lot #: 20140902@47, discard date: 12/31/2014. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs GLUTATHIONE, 100 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140718@4, discard date: 10/16/2014 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs HYALURONIDASE, 240 u/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140818@27, discard date: 2/21/2015 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs HYDROXOCOBALAMIN-preservative free (B12), 1mg/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140717@6, discard date: 10/15/2014 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs HYDROXOCOBALAMIN- preservative (B12), 1mg/mL, injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140729@18, discard date: 10/27/2014 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs HYDROXYPROGESTERONE CAPROATE (SESAME OIL), 250mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140718@1/5, discard date: 1/14/2015; Lot #: 20140813@25, discard date: 2/9/2015; Lot #: 20140903@32, discard date: 3/2/2015. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs LIDOCAINE HCL (REPKG-STERILE), 4%, solution for irrigation, 5 mL, 6 mL, and 7 mL plastic dropper bottle, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140815@12, discard date: 2/16/2015 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs METHYCOBALAMIN, preservative free, 10mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140729@16/1, discard date: 11/26/2014 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs METHYCOBALAMIN, preservative free, 1mg/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140722@2/2, discard date: 1/18/2015; Lot #: 20140910@40/2, discard date: 3/9/2015. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs METHYCOBALAMIN, preservative free, 20mg/mL, injectable, 0.3 mL or 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140718@2/0.3, discard date: 1/14/2015; Lot #: 20140808@4/0.3, discard date: 2/4/2015; Lot #: 20140902@36/1, discard date: 3/1/2015; Lot #: 20140902@37/0.3, discard date: 3/1/2015; Lot #: 20140912@22/1, discard date: 3/11/2015. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs METHYCOBALAMIN, preservative, 1mg/mL, injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140715@2, discard date: 10/13/2014; Lot #: 20140724@10, discard date: 10/22/2014; Lot #: 20140812@14, discard date: 11/1/2014; Lot #: 20140826@5, discard date: 11/1/2014; Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs MITOMYCIN, 0.2mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140913@1, discard date: 10/28/2014 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs MITOMYCIN, 0.3mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140913@4, discard date: 10/28/2014 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs OMNIPAQUE, 300mgI/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140711@1, discard date: 1/7/2015; Lot #: 20140814@22, discard date: 2/10/2015; Lot #: 20140815@13, discard date: 2/11/2015. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs PAPAV HCL/PHENTOL/PROSTAGL, 12mg/1mg/10mcg, injectable, 1.25 mL glass vial or 1.7 ml glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140827@30, discard date: 10/11/2014; Lot #: 20140910@28/1.7, discard date: 10/25/2014; Lot #: 20140917@2/1.25, discard date: 11/1/2014. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs PAPAVERINE HCL/PHENTOLAMINE/ALPROSTADIL, 21.82mg/0.91mg/45mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140722@16/1.7, discard date: 12/3/2014; Lot #: 20140728@43/2, discard date: 12/3/2014. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs PAPAVERINE HCL, with preservative, 30 mg/mL, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140903@14/1.25, discard date: 10/18/2014 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs PAPAVERINE HCL/PHENTOLAMINE MES/ALPROSTADIL, 22mg/0.8mg/8mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140901@3, discard date: 10/19/2014 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs PAPAVERINE HCL/PHENTOLAMINE MES/PROSTAGLANDIN, 23mg/0. 96mg/19.23mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140708@30, discard date: 12/2/2014 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs PAPAVERINE HCL/PHENTOLAMINE/PROSTAGLANDIN, 27.7mg/0.45mg/45.45mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140912@25, discard date: 10/27/2014 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs PAPAVERINE/PHENTOLAMINE/ALPROSTADIL, 26.5mg/0.98mg/58.9mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140910@48/1.25, discard date: 10/25/2014; Lot #: 20140911@11/1.25, discard date: 10/26/2014; Lot #: 20140916@17/1.25, discard date: 10/31/2014. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.16mg/0.57mg/19.45mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140728@39, discard date: 12/3/2014; Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.44mg/0.64mg/5.8mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140910@42, discard date: 1/25/2015 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.64mg/0.58mg/5.8mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140828@4/1.7, discard date: 10/15/2014 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs PREDNISOLONE Sodium Phosphate, 1%, Ophthalmic, 1 mL plastic dropper bottle, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140902@22, discard date: 10/17/2014 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs PROCAINE HCL (BUFF), 1%, injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140905@11/10, discard date: 12/4/2014 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs PYRIDOXINE HCL, with preservative, 100 mg/mL, injectable, 30 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140715@18, discard date: 10/13/2014; Lot #: 20140917@18, discard date: 12/16/2014; Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs SODIUM CHLORIDE INHALATION, 7%, Solution for inhalation, 3 mL plastic vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140916@23, discard date: 10/31/2014 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs TESTOSTERONE CYPIONATE (GRAPE SEED OIL/COMPOUNDED), 200mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140812@7, discard date: 2/8/2015; Lot #: 20140910@41, discard date: 3/9/2015; Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs TESTOSTERONE CYPIONATE (SESAME OIL/CMPD), 200mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140714@51, discard date: 1/10/2015 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs TOBRAMYCIN, 480mg/1000 mL, solution for irrigation, 500 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140912@16, discard date: 10/17/2014 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs TRIESENCE, 8mg/2.0mL, Injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140909@6, discard date: 10/24/2014 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs VANCOMYCIN, 1mg/0.1mL, injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070 Lot #: 20140905@32, discard date: 10/20/2014 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Drugs VITAMIN B COMPLEX (PRES) injectable, 100mg, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070. Lot #: 20140811@5, discard date 10/16/2014 Lot #: 20140827@12, discard date 11/25/2014 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Oregon Compounding Centers, Inc. dba Creative Compounds
Devices Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR PAY LOT: 295424 STERILE Expiration May 2019 Manufacturing Date May 2014 Model No. 321334-000, lot number 295424 Class II The single leg of the PAY connector has been observed to become detached. Dokitz NovoSci
Drugs Candesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3618-3 Lot #: KR3924, KR3926; Exp. 11/15 Class III Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities. Apotex Inc.
Drugs Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3619-3 Lot # KR3933; Exp.10/15 Lot # KR3935, KR3934; Exp.11/15 Class III Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities. Apotex Inc.
Drugs Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 90-count bottles (NDC 60505-3620-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326 Lot #: a) KR3943; Exp. 11/15 Lot #: b) KT6058, KT6060; Exp. Date 11/15 Class III Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities. Apotex Inc.
Drugs Candesartan Cilexetil Tablets, 32 mg, a) 30-count bottle (NDC 60505-3621-3) b) 90-count bottles (NDC 60505-3621-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326 Lot #: a) KR3955; Exp. 10/15, KV0430, Exp. 11/15 Lot #: b) KT6063; Exp. 10/15 Class III Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities. Apotex Inc.
Drugs Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, Rx ONLY, Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-4788-10 Lot 3H43, Exp. 02/15 Class II Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point. Pharmaceutical Associates Inc
Food Organic Steam Treated Ginger Tea Bag Cut Item number 1641 USDA Organic Net Weight: 30 lbs. . High Quality Organics Reno, NV 89506 GINTBC lot 13118; GINOV lot 13613; both with expiry dates of 9/24/16. Class I High Quality Organics was notified by customer that representative sample of Organic Ginger (Tea Bag Cut) tested positive for Salmonella High Quality Organics, Inc.
Drugs Obagi Nu-Derm Clear, AM PM 3, Skin Bleaching and Corrector Cream, Hydroquinone USP, 4%, Rx Only, Net Wt. 2 OZ. (57 g) bottle, Dist by OMP Inc, Long Beach CA 90802, Made in USA, NDC 62032-101-36 Lot #: 13I1218, Product/Part #: 362032101361, Exp 09/30/2016 Class II Labeling: Label Mix-Up; Containers of the Obagi Nu-Derm Clear pre-labeled bottles were inadvertently introduced into the Obagi Exfoderm Forte packaging line. Therefore customers which ordered Clear RX actually had contents of Exfoderm forte. Obagi Medical Products
Devices COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological N/A Class II Error in the software. A deviation between reconstructed and planned dose distribution may not be detected prior to treatment and this can result in an over or under-estimation of the pretreatment delivered dose. Iba Dosimetry Gmbh
Food Bulk packed Wheat Cheese Calzone 48 Servings KEEP FROZEN NET WEIGHT 15.00 lbs Inspected By The U.S. Dept of Agriculture Distributed by: Giorgio Foods, Inc., PO Box 96, Temple, PA 19560 Manufactured 3/27/2014 Best by 3/27/2015 Product 8512 Lot 14086 Best by 3/27/2015 Product 8512 Lot 14086 Class II Calzone recalled due to potential metal contamination. Product manufactured for the National School Lunch Program. Giorgio Foods Inc
Food Whole Foods Vegan Gingersnap Cookies, 6pk (10-oz), packaged in flexible plastic with twist tie Sell By date October 28, 2014 Class I Product mislabeled- undeclared walnut, almond, milk, soy and egg. Whole Food Market
Drugs Loratadine 24 HR-OTC,10 mg, 30-count bottle, Manufactured by Novartis Consumer Health, Parsippany, NJ 07054, Distributed by Physicians Total Care, Tulsa OK 74146, NDC 54868-5268-00 Lot #: 68GA, 68WE, 6A9W, 6AIT, 6ALI, 6936; Exp. 09/13 Lot  ...
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Class III Failed Tablet/Capsule Specifications: Affected lot numbers may contain chipped or broken tablets. Physicians Total Care, Inc.
Drugs CEPHALEXIN MONOHYDRATE CAPSULES,USP, 500 mg, 20-count bottle, Rx only, Manufactured for Caraco Pharmaceuticals, Detroit, MI 48202 by Sun Pharmaceuticals, Fort Worth, TX 76155 and repackaged by Physicians Total Care, Inc., Tulsa, OK 74146-6233 Lot Code: 79MI (Exp. Date 01/31/2015), 79SF (Exp. Date 01/31/2015), 7AH5 (Exp. Date 06/30/2015) Class II CGMP deviations: Products were manufactured with active pharmaceutical ingredients that were not manufactured with good manufacturing practices. Physicians Total Care, Inc.
Drugs Z-COTE HP 1 TRANSPARENT ZINC OXIDE, Zinc Oxide (and) Triethoxycaprylylsilane, Powder, NET: 22 KG, Packaged in double plastic liners in a single fiber carton, FOR MANUFACTURING, PROCESSING OR REPACKING, BASF Corporation, Florham Park, NJ Lot Codes: CNNI2901, CNNI2902 Class III cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lots of Z-COTE HP 1. Nanophase Technologies Corporation
Food Strawberry flavored gelatin mix desert BEST BEFORE/APRIL/2016 B.NO:BA-(STR) Class II Voluntary recall of strawberry flavored gelatin mix and mango flavored gelatin mix which were found to contain undeclared colors, FD& C Red # 40, FD&C Yellow #5, and FD&C Yellow #6. U.B.C Food Distributors, LLC
Food Mango flavored gelatin mix desert Best Before / APRIL /2016 B.NO:BA (MAN) Class II Voluntary recall of strawberry flavored gelatin mix and mango flavored gelatin mix which were found to contain undeclared colors, FD& C Red # 40, FD&C Yellow #5, and FD&C Yellow #6. U.B.C Food Distributors, LLC
Food Bailey Farms, Fresh Serrano Chile Peppers, Oxford, NC 27565. Lot #1460410, Date: 10/05/2014 Class I Product was found to be contaminated with Salmonella Bailey Farms, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W2001148110631; W2001148110632; W2001148110633; W2001148110721; W2001148110722; W200114811083; Class III Plateletphereis products lacking assurance of proper leukoreduction were distributed. American National Red Cross (the)
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