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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 1941–1960 of 17,711 recalls

Class IITerminated

Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93

Aurobindo Pharma USA Inc.

Failed dissolution specifications - results obtained were below spec average.

August 2, 2023 · DrugView details →

Class IITerminated

Helix CBD Clinical Cream (Menthol 7.4%), packaged in a)3 gm pouches (NDC30775-054-01), b)2 fl. oz. tubes (NDC 30775-054-02), and c) 4 fl. oz. tubes (NDC 30775-054-04), Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004

Parker Laboratories, Inc.

CGMP Deviations

August 2, 2023 · DrugView details →

Class IITerminated

Protex Foaming Hand Sanitizer (Benzalkonium Chloride 0.13%), packaged in a) 2 fl oz/60 mL Pump bottles (NDC 30775-040-02) and b)18 fl. oz./550 ml Pump Bottles (NDC 30775-040-18), Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004

Parker Laboratories, Inc.

CGMP Deviations

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 IITerminated

Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-617-08

Aurobindo Pharma USA Inc.

cGMP deviations: Batch was released prior to approval.

July 21, 2023 · DrugView details →

Class IICompleted

Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules per carton, Rx Only, For Oral Use Only - Not For Inhalation or Injection, Must be Diluted, Manufactured by: The Ritedose Corporation Columbia, SC 29203 for Ritedose Pharmaceuticals, LLC Columbia, SC 29203, NDC 76204-025-96.

The Ritedose Corporation

CGMP deviation: product released prior to supplier approval.

July 21, 2023 · DrugView details →

Class IITerminated

Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-616-08

Aurobindo Pharma USA Inc.

cGMP deviations: Batch was released prior to approval.

July 21, 2023 · DrugView details →

Class IITerminated

FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx Only, Single Dose Container, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC# 70004-0253-40

SCA Pharmaceuticals

cGMP deviations: due to shipment of rejected units.

July 20, 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 IITerminated

HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2011-1

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility: Lack of validation data for sanitization cycles

July 17, 2023 · DrugView details →

Class IITerminated

morphine in 0.9% sodium chloride, 125 mg/25 mL, (5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2041-2

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility: Lack of validation data for sanitization cycles

July 17, 2023 · DrugView details →

Class IITerminated

fentaNYL in 0.9% sodium chloride, 5000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2074-1

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility: Lack of validation data for sanitization cycles

July 17, 2023 · DrugView details →

Class IITerminated

midazolam in dextrose 5%, 50 mg /50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-4036-1

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility: Lack of validation data for sanitization cycles

July 17, 2023 · DrugView details →

Class IITerminated

fentaNYL, 1250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-7

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility: Lack of validation data for sanitization cycles

July 17, 2023 · DrugView details →

Class IITerminated

fentaNYL, 5000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-5

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility: Lack of validation data for sanitization cycles

July 17, 2023 · DrugView details →

Class IITerminated

HYDROmorphone added to 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 100 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2010-3

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility: Lack of validation data for sanitization cycles

July 17, 2023 · DrugView details →

Class IITerminated

fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-4

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility: Lack of validation data for sanitization cycles

July 17, 2023 · DrugView details →

Class IITerminated

PHENYLephrine in 0.9 sodium chloride, 800 mcg /10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6008-1

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility: Lack of validation data for sanitization cycles

July 17, 2023 · DrugView details →

Class IITerminated

succinylcholine, 200 mg/10 mL, (20 mg/mL), 10 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6011-2

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility: Lack of validation data for sanitization cycles

July 17, 2023 · DrugView details →

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