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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 401–420 of 1,000 recalls

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 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 →

Class IITerminated

morphine in 0.9% sodium chloride, 1 mg/1 mL, (1 mg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2040-1

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 in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2071-1

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, 50 mg/50 mL (1mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2040-4

Central Admixture Pharmacy Services Inc

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

July 17, 2023 · DrugView details →

Class IITerminated

fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2081-1

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 in dextrose 5%, 300 mcg/30 mL, (10 mcg/mL), 30 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2001-2

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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