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FDA Recalls

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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 181–200 of 1,000 recalls

Class IIITerminated

MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, NJOF, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC:71384-632-05

Imprimis NJOF, LLC

Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.

September 20, 2023 · DrugView details →

Class IIITerminated

Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted before use, NDC 62935-753-75, Manufactured by: Tolmar Inc., Fort Collins, CO 80526, For Tolmar Therapeutics Inc., Fort Collins, CO 80526.

Tolmar, Inc.

Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.

September 12, 2023 · 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 NDC 47335-506-96

SUN PHARMACEUTICAL INDUSTRIES INC

Subpotent: Out of Specification result observed for low assay

September 7, 2023 · DrugView details →

Class IIITerminated

Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE (Eucalyptol 0.092%, menthol 0.042%, Methyl salicylate 0.06%, thymol 0.064%), packaged in 16.9 FL OZ (500 mL) bottle, DISTRIBUTED BY THEKROGER CO. CINCINNATI, OHIO 45202, UPC 011110380807

Vi-Jon, LLC

Incorrect/Undeclared Excipients.

September 5, 2023 · DrugView details →

Class IIITerminated

HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 68084-447-01; Individual Dose NDC: 68084-447-11

Amerisource Health Services LLC

Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.

September 1, 2023 · DrugView details →

Class IIITerminated

Clearasil Rapid Rescue Deep Treatment Pads (Salicylic Acid 2%), packaged in 90-count plastic jar, further packaged in case of 6 jars per case, Distributed by RB Health (US), Parsippany, NJ 07054, NDC 63824-431-90

RB Health (US) LLC

Labeling: Label Error on Declared Strength: The incorrect label on the back of the product packaging.

August 29, 2023 · DrugView details →

Class IIITerminated

Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Rx only, Manufactured by: Contract Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, NDC# 71428-003-60

Contract Pharmaceuticals Limited Canada

Defective Container: slow leakage under the cap

August 23, 2023 · DrugView details →

Class IIICompleted

Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65

Lundbeck LLC

Cross contamination with other products

August 17, 2023 · DrugView details →

Class IIICompleted

Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc, Ann Arbor, MI 48108, NDC 72426-818-03

Esperion

Failed dissolution specifications: below specification results at stability 12-month

August 16, 2023 · DrugView details →

Class IIITerminated

Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL), packaged in 10 x 20 mL vials per carton, NDC 72485-502-01 (single vial), Rx only, Distributed by: Armas Pharmaceuticals, Inc. Freehold, NJ 07728(USA) Manufactured by: Caplin Steriles Limited, India, NDC 72485-502-10

Caplin Steriles Limited

Failed Impurities/Degradation Specifications

August 14, 2023 · DrugView details →

Class IIICompleted

Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 10019-079-01.

Baxter Healthcare Corporation

Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.

August 14, 2023 · DrugView details →

Class IIIOngoing

Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale -Bardez, Goa 403513, India, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-295-01

Glenmark Pharmaceuticals Inc., USA

Subpotent: Out of Specification for Assay Test at the 3-month time point.

August 14, 2023 · DrugView details →

Class IIITerminated

Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC: 71384-311-05.

Imprimis NJOF, LLC

Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.

August 10, 2023 · DrugView details →

Class IIITerminated

PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL Single-dose vial, Manufacturer: Advanced Accelerator Appllications USA, Inc., 57 E. Willow Street NJ 07041, Milburn, USA, NDC 69488-010-61

Advanced Accelerator Applications USA, Inc.

Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date

August 7, 2023 · DrugView details →

Class IIITerminated

0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00

B. Braun Medical Inc.

Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.

August 2, 2023 · DrugView details →

Class IIIOngoing

Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05

ALEMBIC PHARMACEUTICALS, INC.

Failed Impurities/Degradation Specifications

July 27, 2023 · DrugView details →

Class IIITerminated

Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T of D & NH), India, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512. NDC 47335-063-86

SUN PHARMACEUTICAL INDUSTRIES INC

Out of Specification result observed in content uniformity testing

July 18, 2023 · DrugView details →

Class IIITerminated

Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC# 67877-749-57

Ascend Laboratories, LLC

Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.

July 18, 2023 · DrugView details →

Class IIITerminated

Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC# 62756-232-55) and b) 15 mL bottle (NDC # 62756-232-56), Rx only, Distributed by: Sun Pharmaceutical Ind., Inc., NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Ltd., India.

SUN PHARMACEUTICAL INDUSTRIES INC

Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.

July 5, 2023 · DrugView details →

Class IIITerminated

Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S, Manufactured by: Lupin Limited, Aurangabad 431 210 India, NDC 68180-721-03

Lupin Pharmaceuticals Inc.

Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.

June 27, 2023 · DrugView details →

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