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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 321–340 of 1,000 recalls

Class IITerminated

fentaNYL in 0.9% sodium chloride, 2,500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-5

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility:

September 21, 2023 · DrugView details →

Class IITerminated

PHENYLephrine in 0.9% sodium chloride, 1,000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6009-1

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility:

September 21, 2023 · DrugView details →

Class IITerminated

HYDROmorphone in dextrose 5%, 0.5 mg/5 mL, (0.1 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2012-1

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility:

September 21, 2023 · DrugView details →

Class IITerminated

fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-3

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility:

September 21, 2023 · DrugView details →

Class IITerminated

lidocaine 2%, 100 mg/5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6006-1

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility:

September 21, 2023 · DrugView details →

Class IITerminated

HYDROmorphone in 0.9% Sodium Chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2012-1

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility:

September 21, 2023 · DrugView details →

Class IITerminated

ePHEDrine in 0.9% sodium chloride, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6004-1

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility:

September 21, 2023 · DrugView details →

Class IITerminated

rocuronium, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6010-1

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility:

September 21, 2023 · DrugView details →

Class IITerminated

fentaNYL in 0.9% sodium chloride, 1,000 mcg/100 mL, (10 mcg/mL), 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-4

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility:

September 21, 2023 · DrugView details →

Class IITerminated

HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2013-2

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility:

September 21, 2023 · DrugView details →

Class ITerminated

Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940, Made in USA, NDC# 10702-013-01.

KVK-Tech, Inc.

Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.

September 20, 2023 · DrugView details →

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 IITerminated

Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose vials, NDC 71839-122-10; (b) 25 Single-dose vials, NDC 71839-122-25; Rx Only, Mfd. in India for and Distributed by: BE Pharmaceuticals Inc. 203 New Edition Court Cary, NC 27511.

BE PHARMACEUTICALS AG

Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.

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 IITerminated

Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-305-16

VistaPharm LLC

Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results

August 30, 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 IITerminated

Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC 10135-0748-01

Marlex Pharmaceuticals, Inc.

Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.

August 25, 2023 · DrugView details →

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