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FDA Drug Recalls

1,709 recalls · Class III, newest first

Class III · Low risk Terminated Jun 9, 2021

Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13

Reason Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.

AVKARE Inc. NDC 50268-661-13 D-0631-2021

Class III · Low risk Terminated Jun 8, 2021

Ketamine HCl Injection Solution, 10 mg / 2 mL (5 mg/mL), Rx Only, Compounded by Prisma Health Outsourcing Facility 1071 Holland…

Reason Labeling: Incorrect Exp. Date: Incorrect BUD.

Prisma Health Outsourcing Facility D-0648-2021

Class III · Low risk Terminated Jun 8, 2021

Phytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant…

Reason Failed Impurities/Degradation Specifications

Bausch Health Companies, Inc. NDC 68682-170-30 D-0639-2021

Class III · Low risk Terminated Jun 8, 2021

Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC…

Reason Failed Impurities/Degradation Specifications

Bausch Health Companies, Inc. NDC 0187-1704-05 D-0638-2021

Class III · Low risk Terminated Jun 4, 2021

Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Reddy's Mfd. By: Dr. Reddy's Laboratories Limited…

Reason Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities

Dr. Reddy's Laboratories, Inc. NDC 55111-121-05 D-0629-2021

Class III · Low risk Terminated May 26, 2021

Levetiracetam Tablets USP, 250 mg UD 100 Tablets (10x10) boxes, Rx Only, Distributed By: McKesson Corporation 4971 Southridge…

Reason Labeling; Wrong Barcode; error in the machine-readable barcode which could result in some units being read as Naproxen Tablets 500 mg. Product is…

McKesson Corporation dba McKesson Drug Company NDC 63739-795-10 D-0630-2021

Class III · Low risk Terminated May 14, 2021

READYPREP CHG, 2% Chlorhexidine Gluconate Cloth, 2 9x10.5 in (22.9x26.7 cm) Disposable Cloths, Non-Sterile, Single Use Only…

Reason Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate.

Medline Industries Inc D-0624-2021

Class III · Low risk Terminated May 12, 2021

Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American Health…

Reason Failed Impurities/Degradation Specifications

American Health Packaging NDC 68084-915-25 D-0813-2021

Class III · Low risk Terminated May 7, 2021

Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only…

Reason Subpotent and Presence of Particulates .

Sun Pharmaceutical Industries INC NDC 47335-506-96 D-0391-2021

Class III · Low risk Terminated May 4, 2021

Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr. Reddy's Laboratories Limited, Bachupally 500…

Reason Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities

Dr. Reddy's Laboratories, Inc. NDC 55111-121-05 D-0599-2021

Class III · Low risk Terminated May 3, 2021

Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 25 (2 mL multi-dose vial) per carton, Rx only…

Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 contain vials labeled with the incorrect lot number…

Mylan Institutional LLC D-0601-2021

Class III · Low risk Terminated Apr 29, 2021

Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem Laboratories Ltd, Mumbai, 400 013. INDIA…

Reason Presence of Foreign Tablet/Capsule

Ascend Laboratories LLC NDC 67877-446-30 D-0392-2021

Class III · Low risk Terminated Apr 28, 2021

DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC…

Reason Temperature Abuse: Product exposed to temperature outside specified limits.

Fresenius Medical Care Holdings, Inc. NDC 49230-206-30 D-0610-2021

Class III · Low risk Terminated Apr 28, 2021

DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000…

Reason Temperature Abuse: Product exposed to temperature outside specified limits.

Fresenius Medical Care Holdings, Inc. NDC 49230-212-92 D-0609-2021

Class III · Low risk Terminated Apr 28, 2021

DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, packaged…

Reason Temperature Abuse: Product exposed to temperature outside specified limits.

Fresenius Medical Care Holdings, Inc. NDC 49230-209-94 D-0608-2021

Class III · Low risk Terminated Apr 28, 2021

DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL…

Reason Temperature Abuse: Product exposed to temperature outside specified limits.

Fresenius Medical Care Holdings, Inc. NDC 49230-206-92 D-0607-2021

Class III · Low risk Terminated Apr 28, 2021

DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius Medical Care, Waltham…

Reason Temperature Abuse: Product exposed to temperature outside specified limits.

Fresenius Medical Care Holdings, Inc. NDC 49230-0212-50 D-0606-2021

Class III · Low risk Terminated Apr 28, 2021

DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (NDC…

Reason Temperature Abuse: Product exposed to temperature outside specified limits.

Fresenius Medical Care Holdings, Inc. NDC 49230-0209-23 D-0605-2021

Class III · Low risk Terminated Apr 28, 2021

DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA…

Reason Temperature Abuse: Product exposed to temperature outside specified limits.

Fresenius Medical Care Holdings, Inc. NDC 49230-0188-50 D-0604-2021

Class III · Low risk Terminated Apr 27, 2021

Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd. By:KVK-Tech…

Reason Failed Impurities/Degradation Specifications

KVK-Tech, Inc. NDC 10702-055-03 D-0386-2021

Class III · Low risk Terminated Apr 21, 2021

Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC…

Reason Labeling: Incorrect or Missing Lot and/or Exp Date

Heritage Pharmaceuticals Inc NDC 23155-227-01 D-0367-2021

Class III · Low risk Terminated Apr 20, 2021

Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after constitution, Rx only, Distributed by…

Reason Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead of male…

Genentech Inc D-0357-2021

Class III · Low risk Terminated Apr 19, 2021

Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10

Reason Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor…

SigmaPharm Laboratories LLC NDC 42794-017-10 D-0380-2021

Class III · Low risk Terminated Apr 19, 2021

Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10.

Reason Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor…

SigmaPharm Laboratories LLC NDC 42794-016-10 D-0379-2021

Class III · Low risk Terminated Apr 13, 2021

Dry Eye Test, Fluorescein Sodium, Ophthalmic Strips USP (0.12mg Fluorescein Sodium), 100 Sterile Strips (50 Pouches of 2 Strips…

Reason Subpotent Drug

Nomax Inc D-0387-2021