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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 381–400 of 1,000 recalls

Class IIITerminated

Lidocaine Ointment USP, 5% Rx Only, Net Wt 35.44 g(1 1/4 oz)packaged in a laminat tube, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-008-14.

Teligent Pharma, Inc.

Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing.

July 29, 2021 · DrugView details →
Class IIITerminated

Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated Tablets/ 500 mg each, Distributed by Amerisource Bergen, 1300 Morris Drive, Chesterbrook, PA, 19087, NDC 46122-649-71

LNK International, Inc.

Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet'

July 7, 2021 · DrugView details →
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 →
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