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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 221–240 of 1,000 recalls

Class IIITerminated

Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC 42808-103-06 UPC 3 42808 10306 5; b) 12 fl oz (354.8 mL) NDC 42808-103-12 UPC 3 42808 10312 6, Rx only, Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747

Monarch PCM, LLC

Subpotency: one product for active ingredient assay and another one for preservative assay

September 1, 2021 · DrugView details →
Class IIITerminated

Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801 NDC 59746-329-90

Jubilant Cadista Pharmaceuticals, Inc.

Subpotent

August 20, 2021 · DrugView details →
Class IIITerminated

Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Thymoorgan Pharmazie GmbH Schiffgraben 23, 38690 Gosfar, Germany Distributed by Hikma USA Inc. Berkeley Heights, NJ 07922, NDC 0143-9240-01

Hikma Pharmaceuticals USA Inc.

Labeling: Not elsewhere classified: Mislabeling

August 5, 2021 · DrugView details →
Class IIITerminated

Avicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH200 NF, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711

DuPont Nutrition USA, Inc

Out of specification results for conductivity.

August 5, 2021 · DrugView details →
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 →
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