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U.S. Department of Health and Human Services

Enforcement Report - Week of October 21, 2015

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Veterinary Atenolol 6.25 mg/0.1 mL Vet Gel All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Protamine Zinc for insulin (PZI), 100 units/1mL Vet Insulin All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Diazepam, 5mg/1ml Vet Injection All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Medroxyprogesterone, 100mg/1ml Vet Injection All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Baytril (enrofloxacin) 0.68 mg/1mL Vet Suspension All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Tramadol 10mg/ml Vet Suspension All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Gabapentin 10mg/1ml Vet Suspension All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Methimazole 10mg/1ml Vet Suspension All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Sam-e 180mg/2ml Vet Suspension All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Enalapril 1.25mg/1ml Vet Suspension All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Ursodiol 100mg Vet Capsule All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Phenobarbital 10mg Capsule All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Doxycycline 150mg Vet Capsule All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Trilostane 140mg/1ml Vet Suspension All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Fluoxetine 2.5mg/1ml Vet Suspension All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Benazepril 2.5mg/1ml Vet Suspension All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Cisapride 3.5mg Vet Capsule All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Metronidazole 30mg/1ml Vet Suspension All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Theophylline 20mg SR Vet Capsules All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Glipizide 2.5mg/0.1ml Vet Gel All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Amlodipine 0.625mg/0.1ml Vet Gel All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Budesonide 0.5mg/1ml Vet Suspension All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Zonisamide 18.75mg Vet Capsule All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary DES 0.25mg Vet Capsule All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Griseofulvin 25mg/1ml Vet Suspension All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary PPA 25mg Vet Capsule All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Meloxicam 0.5mg/1ml Vet Suspension All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Chlorpheniramine 2mg/0.1ml Vet Gel All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Minocycline 360mg/5ml Vet Suspension All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Paroxetine 5mg/ml Vet Suspension Tuna All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Itraconazole 35mg Vet Treats (Tuna Flavor) All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Furosemide 10m/1ml Vet Suspension All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Aluminum Hydroxide 30mg Vet Capsule All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Stanazol 4mg Vet Capsule All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Clindamycin 60mg/1ml Vet Suspension All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Prednisolone 5mg/1ml Vet Suspension All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Piroxicam 2.5mg/1ml Vet Suspension All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Azathioprine 10mg Vet Capsule All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Diltiazem SR 30mg Vet Capsule All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Amitriptyline 10mg/0.1ml Vet Gel All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Clomipramine 10mg Vet Capsule All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Prazosin 0.5mg Vet Capsule All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Cyclosporin 0.2% Opth Drops All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Tacrolimus 0.02% Opth Drops All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Omeproazole 2gm/15mls All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Potassium Bromide 250 mg/1ml Suspension All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Pergolide 0.25mg/.5ml Suspension All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary ACTH 80 Units/ml Injection All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Cefpodoxime 30 mg/ml All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Rimadyl 25mg/0.2ml Transdermal All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Aspirin 2.8mg Capsule All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Trazodone 13mg Caps All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Anastrozole 0.1mg Capsule All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Iodochlorhydroxyquin All lots Class II The products were produced under conditions that create a high potential for contamination. Health Innovations Pharmacy, Inc
Veterinary Desmopressin Opthalmic Use, sterile solution, 0.01%, eye drops, 5 mL droptainer, Rx only, dispensed by Montana Compounding Pharmacy in Missoula, MT. Lot 02172015:48@11; Expiry date: 10/15/2015; Lot 04152015:29@7; Expiry date: 12/11/2015; Lot 05052015:31@9; Expiry date: 12/31/2015; Class II Desmopressin Opthalmic Use, 0.01%, eye drop sterile solution is recalled due to lack of sterility assurance. Montana Compounding Pharmacy
Veterinary Sulmet (sulfamethazine sodium) Drinking Water Solution, 12.5%, antibacterial for animal use only, packaged in plastic containers. Net Contents: 16 fl oz (473 ml). NADA 006-084. NDC 0010-4708-01. The responsible firm name on the label is Boehringer Ingelheim Vetmedica, Inc. St. Joseph, MO. lot 120582, exp. 31 May 15; lot 120566, exp. 31 May 15; lot 120784, exp. 31 Jul 15; lot 120922, exp. 31 Aug 15; lot 121048, exp. 30 Sep 15; and lot 121028, exp. 30 Sep 15 Class III Presence of particulate matter not intrinsic to the manufacturing process. Boehringer Ingelheim Vetmedica Inc
Food Sysco Classic All Purpose H and R Flour…. Sysco 25 pound All Purpose Flour: Best By 07/22/2016; Always Save 5 pound All Purpose Flour: Best By 07/23/2016; Best Choice 5 pound All Purpose Flour: Best By 07/23/2016; Hy Top 5 pound All Purpose Flour: Best By 07/24/2016 Class II Foreign material. Shawnee Milling Company, Inc.
Food Shawnee Milling Company Hotel And Restaurant Self Rising Climax Four Net 50 Lbs.; Always Save Self-Rising Flour Enriched Bleached Net Wt 5 LB (2.26kg) in waxed paper bag; Best Choice Flour Self-Rising Enriched Bleached Net Wt 5 LB (2.26 kg) in wax paper bag; HyTop Enriched Flour Bleached Self-Rising Net Wt 5 LB (2.27 kg) in waxed paper bag; Parade Enriched Flour Bleached Self-Rising Net Wt 5 LB (2.27kg) in waxed paper bag; Shawnee Best Self Rising Flour Bleached Enriched Pre-Sifted net Wt. 5 LB. (2.268 kg) in waxed paper bag; Shur fine self-rising bleached & enriched flour Net Wt 5 LB (2.27kg) in waxed paper bag. Climax Flour: Best By 07/24/2016; Always Save: Best By 07/22/2016; Best Choice: Best By 07/22/2016; HyTop: Best By 07/22/2016; Parade: Best By 07/21/2016; Shawnee Best: Best By 07/21/2016, Best By 07/22/2016; Shurfine: Best By 07/21/2016, 07/22/2016 Class II Foreign material. Shawnee Milling Company, Inc.
Devices Toshiba Aquilion CT System TSX-101A system software V6.0 or later Class II it was found that if two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. Toshiba American Medical Systems Inc
Devices Toshiba Aquilion CT System TSX-301A system software V6.0 or later Class II it was found that if two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. Toshiba American Medical Systems Inc
Devices Toshiba Aquilion CT System TSX-301B system software V6.0 or later Class II it was found that if two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. Toshiba American Medical Systems Inc
Devices Toshiba Aquilion CT System TSX-301C system software V6.0 or later Class II it was found that if two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. Toshiba American Medical Systems Inc
Devices Toshiba Aquilion CT System TSX-302A system software V6.0 or later Class II it was found that if two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. Toshiba American Medical Systems Inc
Devices Toshiba Aquilion CT System TSX-303A system software V5.00 - R000 or later Class II it was found that if two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. Toshiba American Medical Systems Inc
Food Glutinous Rice, Net WT. 1000 g, packaged in plastic bottles, UPC 6958020881168, Made in China 881168 Class II Win Luck is recalling Grove Grow Notes Glutinous Rice because it contains undeclared alcohol. Win Luck Trading Inc
Drugs QC Quality Choice Loratadine Orally Disintegrating Tablets, USP 10 mg, 10-count tablets per box, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995, NDC 63868-157-10, UPC 6 35515 95777 0 Batch Numbers: 2644273, Exp 9/30/2016; 2600127, Exp 3/20/2016; 2544486, Exp 7/31/2016 Class III Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc.
Drugs Rite Aid Pharmacy loratadine orally disintegrating tablets USP, 10 mg, packaged in a) 30-count tablets per box, Item 352712, UPC 0 11822 52712 5; b) 60-count tablets per box, Item 353672, UPC 0 11822 53672 1. Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011. Batch Numbers: a) 2658137, Exp 11/30/2016; 2644272, Exp 9/30/2016; 2625093, 2625092 Exp 6/30/2016; 2617892, Exp 5/31/2016; 2610783, Exp 4/30/2016; 2600126, 2600128, Exp 2/29/2016 b) 2625093, Exp 6/30/2016; 2617892, Exp 5/31/2016; 2600128, Exp 2/29/2016 Class III Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc.
Drugs Health Best Choice Care, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Proudly Distributed by: Valu Merchandisers, Co., Kansas City, MO 64111; UPC 0 7003861209 4 Batch Numbers: 2625092, Exp 6/30/2016; 2644265, Exp 9/30/2016; 2600126, Exp 2/29/2016 Class III Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc.
Drugs CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41520-525-69, UPC 3 41520 31346 2; b) Children's 10-count tablets per box NDC 41520-527-69, UPC 3 41520 31455 1; Distributed by: American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086 Batch Numbers: (a) 2617891, Exp 5/31/2016; 2600127, Exp 2/29/2016; 2544487, Exp 7/31/2015; 2610783, Exp 4/30/2016 (b) 2600127, Exp 2/29/2016; 2544487, Exp 7/31/2015; 2617891, Exp 5/31/2016; 2644272, Exp 9/30/2016 Class III Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc.
Drugs CVS Pharmacy, Original Prescription Strength, LORATADINE ORALLY DISINTEGRATING TABLETS, USP, 10 mg, packaged in a) 10-count tablets per box, Item 876239, UPC 0 50428 61152 4, and b) 30-count tablets per box, Item 367404, UPC 0 50428 11367 7, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 Batch Numbers: a) 2644273, 2644265, Exp 9/30/2016; 2617891, 2617892, 2617893, Exp 5/31/2016; 2625093, 6/30/2016; 2544488, 7/31/2016; 2600125, 2600126, 2600127, Exp 2/29/2016; 2610783, Exp 4/30/2016 b) 2600128, Exp 2/29/2016; 2544487, Exp 7/31/2016; 2617893, Exp 5/31/2016; 2644265, Exp 9/30/2016; 2644272, Exp 9/30/2016; 2658138, Exp 11/30/2016 Class III Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc.
Drugs Discount Drug Mart Food Fair, Original Prescription Strength, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by: Drug Mart-Food Fair, Medina, OH 44256, UPC 0 93351 12101 2. Batch Numbers: 2617892, Exp 5/31/2016 Class III Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc.
Drugs Equaline Original Prescription Strength, loratadine orally disintegrating tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41163-528-69, UPC 0 4116347138 2; and b) 30-count tablets per box, NDC 41163-528-31, UPC 0 4116346654 8; Distributed by: Supervalu Inc. Eden Prarie, MN 55344 USA Batch Numbers: a) 2617892, Exp 5/31/2016; 2625092, Exp 6/30/2016; 2544486, 2544488, Exp 7/31/2016; 2600127, Exp 2/29/2016; 2644265, Exp 9/30/2016 b) 2544486, 2544488, Exp 7/31/2016; 2600127, Exp 2/29/2016; 2644265, Exp 9/30/2016 Class III Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc.
Drugs Fred's Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-counts tablets per box, Distributed by: fred's, Inc., 4300 New Getwell Road, Memphis, TN 38118, UPC 0 8457912198 4. Batch Numbers: 2544486, 2544487, Exp 7/31/2016; 2600127, Exp 2/29/2016; 2658140, Exp 11/30/2016 Class III Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc.
Drugs Good Neighbor Pharmacy Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) For kids 10-count tablets per box, NDC 24385-0161-52, ABC # 042-226, UPC 0 8770140650 8; b) For adults 10-count tablets, NDC 46122-0140-52, ABC# 059-535, UPC 0877014065546, Distributed by: AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087 Batch Numbers: a) 2625092, Exp 6/30/2016; 2610783, Exp 4/30/2016 b) 2625093, Exp 6/30/2016, 2610783, Exp 4/30/2016 Class III Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc.
Drugs Health Mart Pharmacy loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by: McKesson, One Post Street, San Francisco, CA 94104, NDC 62011-0073-1, UPC 0 5256913369 9 Batch Numbers: 2544488, Exp, 7/31/2016; 2617892, Exp 5/31/2016; 2625092, Exp 6/30/2016 Class III Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc.
Drugs HEB Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Made with pride & care for HEB, San Antonio, TX 78204, Item code: 188330, UPC 0 4122081968 3 Batch Numbers: 2544486, Exp 7/31/2016; 2600127, Exp 2/29/2016; 2617891, Exp 5/31/2016; 2644265, Exp 9/30/2016 Class III Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc.
Drugs Leader Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by Cardinal Health, Dublin, OH 43017, NDC 37205-745-65, UPC 0 9629512322 7 Batch Numbers: 2617891, Exp 5/31/2016; 2625092, Exp 6/30/2016 Class III Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc.
Drugs Major loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, USA, NDC 0904-5806-15, UPC 3 0904580615 9 Batch Numbers: 2644265, Exp 9/30/2016; 2658140, Exp 11/30/2016; 2625092, 2617891, Exp 5/31/2016; 2600127, Exp 2/29/2016; 2544488, 2544486, Exp 7/31/2016 Class III Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc.
Drugs Ohm Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets, Distributed by Ohm Laboratories, Inc. 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 51660-527-31, UPC 3 5166052731 5 Batch Numbers: 2544486, Exp 7/31/2016; 2617891, Exp 5/31/2016; 2644272, Exp 9/30/2016 Class III Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc.
Drugs Premier Value Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box; Distributed by Chain Drug Consortium, 3301 NW Boca Raton Blvd. Suite 101, Boca Raton, FL 33431, NDC 68016-527-31, UPC 8 4098601899 2 Batch Numbers: 2600126, Exp 2/29/2016; 2644273, Exp 9/30/2016 Class III Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc.
Drugs Safeway Care Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 21130-527-69, UPC 3 2113076240 9); b) 30-count tablets per box (NDC 21130-527-31, UPC 3 2113076252 2) Distributed by Safeway Inc. PO BOX 99, Pleasanton, CA 94566 Batch Numbers: a) 2658140, Exp 11/30/2016; 2625092, Exp 6/30/2016; 2617893, Exp 5/31/2016; b) 2625092, Exp 6/30/2016; 2617893, Exp 5/31/2016; 2644265, Exp 9/30/2016 Class III Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc.
Drugs TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS, , USP, 10 mg, packaged in a) Children's 10-count tablets per box (NDC 36800-528-69, UPC 0 3680010261 3); and b) 10-count tablets per box, (NDC 36800-527-69, UPC 0 3680008395 0); Distributed by Topco Associates, LLC, Elk Grove Village, IL 60007. Batch Numbers: a) 2600127, Exp 2/29/2016; 2617892, Exp 5/31/2016; 2644265, 9/30/2016; 2625092, Exp, 6/30/2016; 2658140, Exp 11/30/2016. b) 2617892, Exp 5/31/2016; 2610783, 4/30/2016; 2644272, Exp 9/30/2016 Class III Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc.
Drugs Up&Up loratadine orally disintegrating tablets, USP, 10 mg, 30-count tablets per box, Distributed by Target Corp, Minneapolis, MN 55403; NDC 11673-527-31, UPC 3 5166052731 5 Batch Numbers: 2617892, 2617893, Exp 5/31/2016; 2625092, 2625093, Exp 6/30/2016; 2658137, 2658138, Exp 11/30/2016 Class III Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc.
Drugs Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 49348-930-01, UPC 0 1093936544 6); and b) 30-count tablets per box (NDC 49348-930-44, UPC 0 1093934944 6) Distributed by McKesson, One Post Street, San Francisco, CA 94104 Batch Numbers: (a) 2544488, Exp 7/31/2016; 26917891, Exp 5/31/2016. (b) 2544488, Exp 7/31/2016; 2617893, Exp 5/31/2016; 2644273, Exp 9/30/2016 Class III Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc.
Drugs Wal-itin Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-coiunt tablets per box, (NDC 0363-0527-69, ITEM 367492,UPC 3 1191717021 3); and b) 30-count tablets per box, (NDC 0363-0527-31, ITEM 254166, UPC 3 191715562 ) Distributed by Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015 Batch Numbers: a) 2625093, Exp 6/30/2016; 2617893, Exp 5/31/2016; 2658137, 2658140, Exp 11/30/2016; 2644265, Exp 9/30/2016 b) 2544486, 2544487, 2544488, Exp 7/31/2016; 2600125, 2600126, 2600127, Exp 2/29/2016; 2644272, 2644273, 2644265, Exp 9/30/2016; 2625092, 2625093, Exp 6/30/2016; 2658137, 2658138, 2658140 Exp 11/30/2016; 2610783, Exp 4/30/2016; 2617891, Exp 5/31/2016. Class III Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc.
Drugs Meijer Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Dist. By Meijer Distribution Inc. 2929 Walker Avenue NW, Grand Rapids, MI 49544. NDC 41250-527-31, UPC 7 6023662291 8 Batch Number: 2610783, Exp 4/30/2016 Class III Superpotent Drug: Out Of Specification (OOS) result for Assay. Ohm Laboratories, Inc.
Devices NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data acquisition and review system, either with or without synchronous digital video. The system is intended for medical purposes to record, measure, store and display full band (FbEEG) cerebral EEG and extracerebral activity for Clinical EEG, Electrocorticography (EcOG), Long Term Monitoring (LTM), Intensive Care Unit (ICU) monitoring and Polysomnography (PSG) Sleep studies. While the Nicolet Neurodiagnostic systems are capable of displaying signals, such as Sp02 and EKG, the system is NOT intended for monitoring such signals for the preservation of life, The Nicolet Neurodiagnostic systems are intended to acquire, analyze, and display data Serial numbers include TS150456M, TR150171M, TR150172M, 1TR150173M, TR150174M, TS150451M, TS150452M, TR150170M, UH150119M, TR150169M, UR150226M, UR150227M, UR150228M, UR150229M, TS150455M, TS150457M, TS150458M, TS150454M, TS150453M, UC150184M, PN151700M, SJ150272M, TT150134M, PN151699M, UR150230M, UR150231M, and SJ150271M. Class II Natus Neurology has discovered that when using he NicoletOne v5.94 software, after exiting the impedance check function and returning to the EEG screen, the impedance check signal remains active in waveform, obscuring the EEG signals. Natus Neurology Inc
Devices The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding. Manufacturing lot 1214-F-403 and 1214-V-424 Class II Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System (CTS-1000) Lot Number 1214-F-403.) to address the potential for a balloon leak which may affect the ability to deliver therapy, when needed. Clinical Innovations, LLC
Biologics Blood and Blood Products for Reprocessing W120615670354 Class II Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed. Michigan Blood
Biologics Source Plasma HS0390253; HS0390624; HS0391116; HS0394920; HS0396621; HS0396909; HS0397754; HS0398009; HS0399515; HS0399760; HS0400430; HS0400690; HS0401284; HS0402049; HS0402382; HS0402969; HS0403425; HS0404290; HS0417294; HS0420581; HS0422529; HS0422944; HS0423621; HS0435777; HS0436087 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. BPL Plasma, Inc. (Hot Springs)
Biologics Platelets Pheresis Leukocytes Reduced W141615174799; W141615193317-part 1; W141615193317-part 2; W141615214437 Class II Blood products, which did not meet acceptable product specifications, were distributed. Puget Sound Blood Center and Program
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W141615214437; W141615252325-part 1; W141615252325-part 2; W141615252325-part 3; W141615252330 Class II Blood products, which did not meet acceptable product specifications, were distributed. Puget Sound Blood Center and Program
Biologics Blood and Blood Products for Reprocessing W333615043015 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Mississippi Valley Reg Bld Ctr
Biologics Cryoprecipitated AHF, Pooled W333615048035 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Mississippi Valley Reg Bld Ctr
Biologics Source Plasma JV0239022; JV0240012 Class II Blood products, collected from a donor who was previously deferred, were distributed. BPL PLasma, Inc.
Biologics Source Plasma WN0432658; WN0433553 Class III Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed. DCI Biologicals Wilmington, Inc.
Biologics Blood and Blood Products for Reprocessing W201114028094 Class III Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. American Red Cross Blood Services
Biologics Source Plasma DF0269326; DF0323556 Class III Blood products, collected from a donor for whom there was no documentation of checking the arm, mouth, or general appearance on the day of donation, were distributed. BPL Plasma, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036314031889 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. BloodCenter of Wisconsin, Inc
Biologics Blood and Blood Products for Reprocessing W036314031889 Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. BloodCenter of Wisconsin, Inc
Food Caravelle ABC Cookies Banh Chu NET WT: 7oz (200gr) Product of Vietnam No lot code information available. Class II Anhing Corporation is recalling Caravelle ABC Cookies because recent analysis revealed each cookie contained a lead level of 0.13 ppm and 13 ppm per labeled serving size. In addition the label did not declare flour as wheat flour, and stated the product contained vegetable oil when it was refined coconut oil. Anhing Corporation
Drugs Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Sterile Unit-Dose Vials, a) 30 count (NDC 0487-0201-03) and b) 60 count (NDC 0487-0201-60) vials per carton, Rx only, Nephron Pharmaceutical Corporation, Orlando, FL a) Lot D4E20A, exp 3/2016 and b) Lot D4C21A, exp 3/2016 Class II Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process Nephron Pharmaceuticals Corp.
Food French Burnt Peanuts, NET WEIGHT 8 OZ (227g) Old Time Candy.com Distributed by Old Time Candy Company LaGrange, OH 44050 www.oldtimecandy.com Ingredients: Dextrose, Citric Acid, Calcium Stearate, Artificial Flavors, Artificial Colors***. May Contain Milk And Soy. There are no codes for this product Class II The firm has the incorrect ingredient statement on the package. The ingredient statement fails to list the allergen "Peanuts", Sugar, artificial colors (Red 3 & Blue 2), and Salt. Old Time Candy
Devices Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG) and glucose (GLU) test procedures. Lot C3091 and Lot C3091A Class III Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control because the assigned control ranges for the Total Cholesterol (TC) and Triglyceride (TRG) analytes are incorrect. Alere San Diego, Inc.
Devices Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. All Lots. Item number and name: 47-2493-481-10 ZNN  ...
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Class II In about 5% of tested samples, the outer tray was found to be compromised. Risks: A damaged outer tray detected during surgery may cause a delay in surgery to obtain another implant. If a compromised packaging is not detected prior or during a surgery by the user, it may lead to periprosthetic infection. This may result in revision or multi-stage revision to treat the infection. Zimmer Gmbh
Devices Inserter for Titanium Elastic Nails (TEN), orthopedic device Part Number 359.219 lot numbers: 1095607 3301017 4826021 5422955 5718485 8006578 8017872 1121876 3325276 4911859 5455364 5718486 8007139 8018319 1641700 3382583 4911860 5455365 5718487 8007472 8114862 1806500 3410330 4969014 5485078 7505411 8008046 8214803 1811056 3430483 4971314 5492810 7565990 8008261 8326267 1811059 3493588 5042001 5496455 7601112 8009205 8424513 1813900 3504996 5066417 5507788 7619995 8009363 8476286 1904339 3524633 5066418 5525235 7670741  ...
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Class II potential for mechanical failures such as breakage. Synthes (USA) Products LLC
Devices -Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices consist of a permanent implant combined with a guidewire based delivery system. The Pipeline and Pipeline Flex embolization device implant is a braided, multi-alloy, mesh cylinder woven from platinum/tungsten and cobalt-chromium-nickel alloy wires. The Pipeline and Pipeline Flex Embolization Devices are indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments. Pipeline Model Number Lot Number FA-77250-16V06 9724629 FA-77350-16V10 A024276 FA-77350-16V12 A012865 FA-77350-18Vl0 A013596 FA-77350-20V12 A012039 FA-77375-14V12 A013029 FA-77375-16Vl2 A011629 FA-77375-16Vl2 A029223 FA-77375-16Vl2 A031361 FA-77375-18V10 A024213 FA-77375-20Vl2 A029315 FA-77400-14V12 A012885 FA-77425-18V12 A026942 FA-77450-14V12 A013028 FA-77475-20Vl2 A012383 FA-77500-16Vl2 A029316 Pipeline Flex Model Number Lot Number PED-400-20VO1 9977371 PED-475-20V01 A047151 PED-375-18V01 9971250 Class II The firm is recalling Pipeline and Pipeline Flex Embolization Devices from U.S. since the devices were shipped with an EU version of the Instructions for Use. Micro Therapeutics Inc, Dba Ev3 Neurovascular
Devices MRIdian® ViewRay® Radiation Therapy System, ViewRay® Is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated. Catalog/Part Number: 10000; Serial Numbers: 100, 101, 102, & 105 Class II ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the couch could move unexpectedly. Viewray Incorporated
Devices Monode, Shortwave Accessory, Model number 0220000, used in conjunction with the Intelect Shortwave Diathermy 100 and Intelect Shortwave Diathermy 400 units. For the clinical application of electromagnetic energy in the radio frequency of 27.12 megahertz to generate deep heat within body tissues. Model #: 02200002 All units received from the manufacture prior to the week of July 12, 2015 Class II Overheating and burning of the wire insulation inside the applicator. DJO, LLC
Food GoGo SQueeZ Applesauce, Apple Apple, individually wrapped in foil pouch in cardboard carton; sizes include: 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack All lots with Best by Dates: 06/29/16 - 07/27/16 Class II Materne North America initiated a voluntary recall of multiple varieties of its GoGo SQueeZ Applesauce due to the potential presence of mold. Materne, North America
Food GoGo SQueeZ Applesauce, Apple Peach Sweet Potato, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack All lots with Best by Dates: 06/29/16 - 07/27/16 Class II Materne North America initiated a voluntary recall of multiple varieties of its GoGo SQueeZ Applesauce due to the potential presence of mold. Materne, North America
Food GoGo SQueeZ Applesauce, Apple Carrot Mixed Berry, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack All lots with Best by Dates: 06/29/16 - 07/27/16 Class II Materne North America initiated a voluntary recall of multiple varieties of its GoGo SQueeZ Applesauce due to the potential presence of mold. Materne, North America
Food GoGo SQueeZ Applesauce, Apple Mango, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack All lots with Best by Dates: 06/29/16 - 07/27/16 Class II Materne North America initiated a voluntary recall of multiple varieties of its GoGo SQueeZ Applesauce due to the potential presence of mold. Materne, North America
Food GoGo SQueeZ Applesauce, Apple Banana, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack All lots with Best by Dates: 06/29/16 - 07/27/16 Class II Materne North America initiated a voluntary recall of multiple varieties of its GoGo SQueeZ Applesauce due to the potential presence of mold. Materne, North America
Food GoGo SQueeZ Applesauce, Apple Pear, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack All lots with Best by Dates: 06/29/16 - 07/27/16 Class II Materne North America initiated a voluntary recall of multiple varieties of its GoGo SQueeZ Applesauce due to the potential presence of mold. Materne, North America
Food GoGo SQueeZ Applesauce, Apple Grape, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack All lots with Best by Dates: 06/29/16 - 07/27/16 Class II Materne North America initiated a voluntary recall of multiple varieties of its GoGo SQueeZ Applesauce due to the potential presence of mold. Materne, North America
Food GoGo SQueeZ Applesauce, Organic Apple, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack All lots with Best by Dates: 06/29/16 - 07/27/16 Class II Materne North America initiated a voluntary recall of multiple varieties of its GoGo SQueeZ Applesauce due to the potential presence of mold. Materne, North America
Food GoGo SQueeZ Applesauce, Organic Apple Peach, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack All lots with Best by Dates: 06/29/16 - 07/27/16 Class II Materne North America initiated a voluntary recall of multiple varieties of its GoGo SQueeZ Applesauce due to the potential al presence of mold. Materne, North America
Food GoGo SQueeZ Applesauce, Apple Pumpkin Cinnamon, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack All lots with Best by Dates: 06/29/16 - 07/27/16 Class II Materne North America initiated a voluntary recall of multiple varieties of its GoGo SQueeZ Applesauce due to the potential presence of mold. Materne, North America
Food GoGo SQueeZ Applesauce, Berry Pear, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack All lots with Best by Dates: 06/29/16 - 07/27/16 Class II Materne North America initiated a voluntary recall of multiple varieties of its GoGo SQueeZ Applesauce due to the potential presence of mold. Materne, North America
Food GoGo SQueeZ Applesauce, Apple Strawberry, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack All lots with Best by Dates: 06/29/16 - 07/27/16 Class II Materne North America initiated a voluntary recall of multiple varieties of its GoGo SQueeZ Applesauce due to the potential presence of mold. Materne, North America
Food GoGo SQueeZ Applesauce, Variety Packs, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack All lots with Best by Dates: 06/29/16 - 07/27/16 Class II Materne North America initiated a voluntary recall of multiple varieties of its GoGo SQueeZ Applesauce due to the potential presence of mold. Materne, North America
Drugs Bravelle 75 IU (urofollitropin for injection, purified) For Subcutaneous or Intramuscular Injection Only, 1 Carton (contains 5 single dose vials of Bravelle, 5 single dose vials of 0.9% Sodium Chloride Inj., USP, 2 mL, and 5 Q-Cap Vial Adaptors) , Rx Only, Manufactured for: Ferring Pharmaceuticals, Inc. Parsippany, NJ 07054, By: Ferring Gmbh, Kiel Germany, NDC 55566-8505-6 Lot #'s: K11813A-1, K11813A-2, Exp 01/16; K11813B-1, K11813C-1, Exp 04/16; K13031A-1, K13031B-1, K13031B-2, Exp 05/16 Class III Subpotent Drug: Stability samples were confirmed to be out of specification for potency at the 12 month time point. Ferring Pharmaceuticals Inc
Food Candy El Pecas Mango Chile Net wt. 1.5oz. UPC: 6 66030 00009 2 Product packaged betwen 15 march to June 30 2015 Class II Perez Casas Enterprises, Inc. is recalling Candy El Pecas Mango Chile and Watermelon Flavor due to undeclared Yellow #5 and Red #40. Perez Casas Enterprises, Inc.
Food Candy El Pecas Paleta de Sandia watermelon lollipops NET WT. 2.5oz Product packaged betwen 15 march to June 30 2015 Class II Perez Casas Enterprises, Inc. is recalling Candy El Pecas Mango Chile and Watermelon Flavor due to undeclared Yellow #5 and Red #40. Perez Casas Enterprises, Inc.
Drugs Methylcobalamin (preservative Free) 1 mg/mL Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 Lot #: 09102015@9, Exp 10/25/15 Class II Lack of assurance of sterility Bedford Pharmacy
Drugs P-P-P (COBAL) 30-1-20/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 Lot #: 08132015@9, Exp 09/27/2015 Class II Lack of assurance of sterility Bedford Pharmacy
Drugs P-P (COBAL) 30-2 /mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 Lot #: 09012015@3, Exp 10/16/2015 Class II Lack of assurance of sterility Bedford Pharmacy
Drugs Methylcobalamin (Bacteriostatic) 1 mg/mL Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 Lot #: 08132015@17, Exp 09/27/2015 Class II Lack of assurance of sterility Bedford Pharmacy
Drugs Hydroxocobalamin 20 mg/mL Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 Lot #: 08042015@3, Exp 09/18/2015 Class II Lack of assurance of sterility Bedford Pharmacy
Drugs Acetylcysteine 10% Opthalmic Solution, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 Lot #: 07232015@1, Exp 09/06/29015 Class II Lack of assurance of sterility Bedford Pharmacy
Drugs Testosterone Cypionate (Complete Formula) 100 mg/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 Lot #: 09082015@12, Exp10/23/2015; 09032015@16, Exp 10/18/2015 Class II Lack of assurance of sterility Bedford Pharmacy
Drugs Testosterone Cypionate (Complete Formula) 200 mg/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 Lot #: 09032015@16 , Exp 10/18/2015 Class II Lack of assurance of sterility Bedford Pharmacy
Drugs P-P-P (COBAL) 30-1-5/mL, Injection,Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 Lot #: 08182015@6, Exp 10/02/2015 Class II Lack of assurance of sterility Bedford Pharmacy
Drugs P-P-P (COBAL) 30-4-40/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 Lot #: 09082015@4, Exp 10/23/2015 Class II Lack of assurance of sterility Bedford Pharmacy
Drugs P-P-P (COBAL) 30-2- 30/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 Lot #: 07112015@5, Exp 09/29/2015 Class II Lack of assurance of sterility Bedford Pharmacy
Drugs P-P (COBAL)30-0.5/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 Lot #: 08262015@9, Exp 10/10/2015 Class II Lack of assurance of sterility Bedford Pharmacy
Drugs P-P (COBAL) 300-30/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 Lot #: 08122015@11, Exp 09/26/2015 Class II Lack of assurance of sterility Bedford Pharmacy
Drugs FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4297-31, UPC 3 0054-4297-31 8. Lot #: 559660P, 559661P, Exp 03/17 Class III CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP. Boehringer Ingelheim Roxane Inc
Drugs FUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4299-31, UPC 3 0054-4299-31 2. Lot #: 559310P, Exp 02/17; 559664B, Exp 04/17 Class III CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP. Boehringer Ingelheim Roxane Inc
Drugs Sedalmex (Acetaminophen 500 mg with Caffeine 65 mg) Pain Reliever tablets, 20-count tablets in blisters per box, Manufactured in Mexico by: Merck, S.A. de C.V./, Imported & Distributed by Midway Importing, Inc., 1807 Brittmoore Rd, Houston, TX 77043, UPC: 1 88436 00017 4. Lot Numbers: M51196, M51197, M51198, Exp 01/17 Class II Cross Contamination With Other Products: Potential cross-contamination of cephalosporin. Midway Importing, Inc
Devices Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head element insertion. Part Number 03.037.025 Lot Numbers 8911887; 8911975; 9166356; 9285766; 9286671; 9319408; 9375245; 9375251; 9388359; 9388360; 9393071; 9393074; 9393075; 9393076; 9409795; 9409796; 9422892; 9422895; 9498455; 9310899; 9310900; 9319407 Class II Certain lots of the Screw Inserter may be etched with incorrect graphics. The orientation of the etched image of the oblique angle on the Screw Inserter may not correspond to the tip of the angle of the instrument. Synthes (USA) Products LLC
Devices 4FR Single Lumen Pressure Injectable PICC; catheter,intravascular,therapeutic,long-term greater than 30 days Material Numbers: ASK-05041-CHC2 ASK-05041-LM4 ASK-05041-QV ASK-05541-MS3 CA-05041-HP CA-05041-HPX CDC-04041-HPK1A CH-04041-HMA EU-04041-HP EU-05041-HPMSB EU-05541-HP EU-05541-HPMSB EU-24041-HP EU-24041-HPMSB EU-24041-IR EU-25041-HP EU-25041-HPMSB EU-25041-IR EU-25541-HP EU-25541-HPMSB EU-25541-IR FR-04041 FR-04041-CF FR-05041 FR-05041-CF PR-04041-HPX PR-05041-HP PR-05541-HPX UK-04041-RDE1 UK-04041-THT UK-05041-HPMIN UK-05041-MSB UK-05041-RDE1 UK-05041-THT with Batch Nos. 23F15E0620 23F15A0584 23F14H0964 23F14F1422 23F13J0289 23F13H0832 23F15C2435 23F14L0090 23F14H0848 23F14F0370 23F14A1352 23F13K0761 23F14H0193 23F15C1236 23F14M0484 23F14L0810 23F14K1361 23F14J0415 23F14E1093 23F14B0844 23F15D0881 23F14L0187 23F15F0752 23F15A1857 23F15D0830 23F14H1112 23F14F1497 23F14C1096 23F14C0640 23F14A1238 23F14A1419 23F14L1144 23F14J1513 23F15D0832 23F15F0147 23F15C0303 23F14J0221 23F14F1504 23F14C0643 23F13K0097 23F13H0994 23F13H0013 23F15F0151 23F15C1553 23F15B0400 23F14K1025 23F14H0328 23F14F1505 23F14C0598 23F13K0003 71F14L0736 71F14K1846 71F15B1940 71F13M1092 71F13L0510 71F14A1536 71F14C0247 71F14B1735 71F14F1289 71F14E2029 71F14J1087 71F14K0628 71F14K0081 71F14L0762 71F14L0323 71F14M0678 71F15A0395 71F15B0648 71F15C0214 71F15D0234 71F15D0053 71F15D1075 23F14G1130 23F14F0115 23F14C0576 23F14A1241 23F13K1064 23F13H0034 23F15D1021 23F14D0713 23F14C0575 23F14A1240 23F13K1065 23F13J1118 23F13H0692 71F13G0655 71F13H1053 71F13H0599 71F13H0225 71F13J0124 71F13J1293 71F13K1289 71F13M0785 71F14A1326 71F14B0312 71F14B0879 71F14E1533 71F14E1967 71F14F1290 71F14G0365 71F14F1358 71F14H0351 71F14H0947 71F14J0869 71F14H1396 71F14K0622 71F14K0082 71F14K1332 71F14M0141 71F15A0152 71F15A1289 71F15A1984 71F15B0638 71F15C1137 71F15D0272 71F15D1059 23F14D1125 23F14D0217 23F14B1013 71F15D1630 71F15F1435 71F14J1734 71F14H1167 71F14M0143 71F15B0996 71F15B0224 71F15C0128 71F15D0578 71F15C1592 71F15D1983 71F15E1582 71F15F1737 71F15E1216 71F15D1909 71F14J1735 71F14H1165 71F15A0163 71F15B0228 71F15C0812 71F15C0215 71F15D0682 71F15D0222 71F15D1717 71F15F1736 71F15E1217 71F15F1863 71F15E1185 71F15F1436 71F15F1310 71F15F2106 71F14H0441 71F14L0582 71F14M0144 71F14M0820 71F15A0123 71F15B1011 71F15A1661 71F15C1593 71F15E0165 71F15F1731 71F15E1220 71F14K1569 71F15D0052 71F13L0991 71F13M1110 71F13M0627 71F14A0698 71F14C0579 71F14D0710 71F14F1217 71F14H0374 71F14J1086 71F14K1198 71F14L1345 71F15A1660 71F15B1938 71F15D1077 71F15D0235 71R15E0455 71F15F1185 71F14K1571 71F13G0162 71F13K1107 71F14A1940 71F14A0150 71F14E2043 71F14F1786 71F14F1844 71F14G1690 71F14K0639 71F14L0577 71F14L1347 71F15A1302 71F15B0662 71F15B1937 71F15D0681 71F15E1403 71F14B1741 71F14E0087 71F14E2044 71F14F1785 71F14J1860 71F15A0300 71F15C2011 71F15E1405 23F14E0187 23F15F0261 23F15E1682 23F15D1561 23F15C1091 23F15D0167 23F15B1878 23F15B0293 23F15A1295 23F15A0633 23F14M0574 23F14K1394 23F14K0462 23F14H1536 23F14G1210 23F14E0751 23F14B0822 23F13J1010 23F13J0221 23F13H0876 RF3065299 23F15F1564 23F15B2204 23F14H1433 23F14E0655 23F14E0173 23F14B1161 23F13K0564 23F14B0718 71F15D0580 71F15D1773 71F13J1276 71F13L0902 71F14C1183 71F14E1122 71F14K1663 71F14L0428 71F15A0864 71F15D1722 71F13L1104 71F13L0390 71F14A1957 71F14A0047 71F14C0588 71F14C1362 71F14G0670 71F14K1035 71F14K0409 71F14L1351 71F14L1201 71F14M0821 71F15B0782 71F15F1735 71F15C0829 71F15D0583 71F13J1277 71F14B0311 71F14D1628 71F14E1530 71F14H0659 71F14J1738 71F14L0743 71F14M0328 71F15A0161 Class II labeling inaccuracy in the Instructions for Use (IFU) and Patient Card. Arrow International Inc
Drugs WellPatch® Capsaicin Pain Relief Patch, 0.025% Natural Capsaicin, External Analgesic, 4 Large Patches, Distributed by Consignor; The Mentholatum Company, Orchard Park, NY, Manufactured by Consignee; Mentholatum (China) Pharmaceuticals, Guangdong China --- NDC 10742-8126-2, UPC 31074201566 Lot numbers: EL016, EL 026, EL036, EL046, Expiration Date: 12/2016 Class II Labeling: Incorrect Instructions; The word not is missing from the following sentences "do bandage tightly or cover with any type of wrap except clothing and "do use with a heating pad or with other heat sources in the Drug Facts panel "Warning" section The Mentholatum Co.
Devices Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter, or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vasculatuure systems. Lot no. 37603 Expiration date: September 2016 Class II One Distal Access Catheter intended for distribution in Korea, was found at a US location. Concentric Medical Inc
Food TASTEE Plain Caramel Apple, www.tasteeapple.com NET WT. 3 OZ 85g 0 35266 00027 3 "THIS PRODUCT CONTAINS THE FOLLOWING ALLERGENS: MILK AND SOYBEAN***" TASTEE APPLE INC. NEWCOMERSTOWN, OH 43832 best if used by 9/29 Class II The firm was notified by a customer that their Plain Caramel Apples contains peanuts and the label does not list peanuts in the ingredient statement.. Tastee Apple Inc
Drugs Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 0591-2720-60; UPC 3 05912 72060 3. Lot: 1037736A, Exp 03/18 Class II Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint. Actavis Laboratories, FL, Inc.
Devices Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes 2.7MM/3.5MM VA-LCP Extended Medial Distal Humerus Plates 10H/RT/189mm-Sterile The Synthes 2.7 mm/3.5 mm Variable Angle LCP Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically, " Distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus. " Olecranon and proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna. Product Description Part Numbers Lot Numbers 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile 02.117.410S 8009075 2.7MM/3.5MM VA-LCP Extended Medial Distal Humerus Plates 10H/RT/189mm-Sterile 02.117.610S 8007085 Class II The 2.7MM/3.5MM VA-LCP Humerus Plates were found to be labeled incorrectly. Part number 02.117.410S was incorrectly etched with part number 02.117.610S Synthes (USA) Products LLC
Drugs Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-04), Rx Only, Mfg for: Apotex Corp., Weston, FL 33326. Lot #: a) MF0537, Exp 07/2016; b) MF8090, MF0532, Exp 07/2016 Class II Lack of Assurance of Sterility: Failed preservative effectiveness testing Apotex Inc.
Drugs Fenofibric Acid Tablets, 35 mg, 30-count bottles, labeled as a) FIBRICOR (fenofibric acid) Tablets, NDC 13310-101-07, UPC 3 13310-101-07 8, Manufactured for: AR SCIENTIFIC, INC., Philadelphia, PA 19124 USA; by: MUTUAL PHARMACEUTICAL CO., INC., Philadelphia, PA 19124 USA; b) FIBRICOR (fenofibric acid) Tablets, NDC 49708-101-07, UPC 3 49708 10107 8; c) Fenofibric Acid Tablets, NDC 53489-677-07, UPC 3 53489 67707 3, Rx only, Manufactured by Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. Lot #: a) 6631401, Exp 03/16; b) 6631403, Exp 03/16; 6697001, Exp 06/17; c) 6631402, Exp 03/16; 6663401, Exp 10/16; 6697002, 6697004, Exp 06/17 Class III Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug product. Tribute Pharmaceuticals US Inc.
Drugs Fenofibric Acid Tablets 105 mg, Rx only, labeled as a) FIBRICOR (fenofibric acid) Tablets, 30-count bottles, NDC 13310-102-07, UPC 3 13310-102-07 5; b) FIBRICOR (fenofibric acid) Tablets, 90-count bottles, NDC 13310-102-90, UPC 3 13310-102-90 7; Manufactured for: AR SCIENTIFIC, INC., Philadelphia, PA 19124 USA; by: MUTUAL PHARMACEUTICAL CO., INC., Philadelphia, PA 19124 USA; and c) FIBRICOR (fenofibric acid) Tablets, 30-count bottles, NDC 49708-102-07, UPC 3 49708 10207 5; d) FIBRICOR (fenofibric acid) Tablets, 90-count bottles, NDC 49708-102-90, UPC 3 49708 10290 7; e) Fenofibric Acid Tablets, 30-count bottles, NDC 53489-678-07, UPC 3 53489 67807 0; f) Fenofibric Acid Tablets, 90-count bottles, NDC 53489-678-90, UPC 3 53489 67890 2; Manufactured by Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124, Distributed by: Sun Pharmaceutical Industries, Inc, Cranbury, NJ 08512; g) Fenofibric Acid Tablets, 30-count bottles, Professional Sample, NDC 53489-678-87, UPC 3 53489-678-87 2; Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA. Lot numbers: a) 6623102, Exp 01/16; b) 6623104, Exp 01/16; c) 6674403,  ...
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Class III Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug product. Tribute Pharmaceuticals US Inc.
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