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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 221–240 of 1,000 recalls

Class IIITerminated

LEUKINE (Sargramostim) for Injection, 250 mcg/ vial, 5mL vials, 5 (250 mcg vials) per box, Rx only, Mfd by Partner Therapeutics, Inc. Lexington, MA 02421, NDC 71837-5843-5

Partner Therapeutics Inc

FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.

June 23, 2021 · DrugView details →

Class IIITerminated

Erythromycin Topical Gel, 2%, Net Wt. (a) 30 g,(NDC 52565-033-30) (b) 60 g,(NDC 52565-033-60) Rx Only, Manufactured by: Teligent Pharma, Inc. , Buena, NJ 08310,

Teligent Pharma, Inc.

Failed Impurities/Degradation Specifications

June 22, 2021 · DrugView details →

Class IIITerminated

Erythromycin Topical Solution USP, 2% 60 mL, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310, NDC 52565-027-59

Teligent Pharma, Inc.

Failed Impurities/Degradation Specifications

June 22, 2021 · DrugView details →

Class IIITerminated

B-Force, Homeopathic, 1 Fl Oz (30 mL) bottle, Distributed by: BioActive Nutritional, Inc., Melbourne, FL 32935, NDC 43857-0576-1

Grato Holdings, Inc.

Superpotent

June 18, 2021 · DrugView details →

Class IIITerminated

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

AVKARE Inc.

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

June 9, 2021 · DrugView details →

Class IIITerminated

Ketamine HCl Injection Solution, 10 mg / 2 mL (5 mg/mL), Rx Only, Compounded by Prisma Health Outsourcing Facility 1071 Holland Rd. Suite 2 Simpsonville, SC 29681. NDC: 73463-0100-01

Prisma Health Outsourcing Facility

Labeling: Incorrect Exp. Date: Incorrect BUD.

June 8, 2021 · DrugView details →

Class IIITerminated

Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ, 08807, USA, NDC 0187-1704-05.

Bausch Health Companies, Inc.

Failed Impurities/Degradation Specifications

June 8, 2021 · DrugView details →

Class IIITerminated

Phytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA, NDC 68682-170-30

Bausch Health Companies, Inc.

Failed Impurities/Degradation Specifications

June 8, 2021 · DrugView details →

Class IIITerminated

Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Reddy's Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, 500-090 India, NDC 55111-121-05.

Dr. Reddy's Laboratories, Inc.

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

June 4, 2021 · DrugView details →

Class IIITerminated

Levetiracetam Tablets USP, 250 mg UD 100 Tablets (10x10) boxes, Rx Only, Distributed By: McKesson Corporation 4971 Southridge Blvd., Suite 101 Memphis, TN 38141 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 090, India NDC 63739-795-10

McKesson Corporation dba McKesson Drug Company

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

May 26, 2021 · DrugView details →

Class IIITerminated

READYPREP CHG, 2% Chlorhexidine Gluconate Cloth, 2 9x10.5 in (22.9x26.7 cm) Disposable Cloths, Non-Sterile, Single Use Only, Manufactured by Medline Industries, Inc., Northfield, IL 60093 USA. NDC: 53329-244-01

Medline Industries Inc

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

May 14, 2021 · DrugView details →

Class IIITerminated

Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American Health Packaging Columbus, OH 43217, NDC 68084-915-25

American Health Packaging

Failed Impurities/Degradation Specifications

May 12, 2021 · DrugView details →

Class IIITerminated

Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC 47335-506-96

SUN PHARMACEUTICAL INDUSTRIES INC

Subpotent and Presence of Particulates .

May 7, 2021 · DrugView details →

Class IIITerminated

Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr. Reddy's Laboratories Limited, Bachupally 500 090, India, NDC 55111-121-05.

Dr. Reddy's Laboratories, Inc.

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

May 4, 2021 · DrugView details →

Class IIITerminated

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, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 USA; Manufactured by: Mylan Institutional, Galway, Ireland. NDC: 67457-196-02

Mylan Institutional LLC

Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 contain vials labeled with the incorrect lot number 200901.

May 3, 2021 · DrugView details →

Class IIITerminated

Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem Laboratories Ltd, Mumbai, 400 013. INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054, NDC 67877-446-30.

Ascend Laboratories LLC

Presence of Foreign Tablet/Capsule

April 29, 2021 · DrugView details →

Class IIITerminated

DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius Medical Care, Waltham, MA 02451, NDC 49230-0212-50

Fresenius Medical Care Holdings, Inc.

Temperature Abuse: Product exposed to temperature outside specified limits.

April 28, 2021 · DrugView details →

Class IIITerminated

DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL, packs of 5, Rx only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-212-92

Fresenius Medical Care Holdings, Inc.

Temperature Abuse: Product exposed to temperature outside specified limits.

April 28, 2021 · DrugView details →

Class IIITerminated

DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (NDC 49230-0209-23), b) 3000 mL (NDC 49230-209-30) and c) 5000 mL (NDC 49230-209-50) Rx only, Fresenius Medical Care NA Waltham, MA 02451

Fresenius Medical Care Holdings, Inc.

Temperature Abuse: Product exposed to temperature outside specified limits.

April 28, 2021 · DrugView details →

Class IIITerminated

DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, packaged in a) 2500 mL (NDC 49230-209-94) and b) 2000mL, packs of 5 (NDC 49230-209-92) Fresenius Medical Care NA, Waltham, MA 02451,

Fresenius Medical Care Holdings, Inc.

Temperature Abuse: Product exposed to temperature outside specified limits.

April 28, 2021 · DrugView details →

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