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FDA Drug Recalls

14,801 recalls, newest first

Class III · Low risk Terminated Aug 2, 2023

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

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

B. Braun Medical Inc. NDC 0264-5802-00 D-1083-2023

Class II · Moderate risk Terminated Jul 21, 2023

Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279…

Reason cGMP deviations: Batch was released prior to approval.

Aurobindo Pharma USA Inc. NDC 59651-617-08 D-1088-2023

Class II · Moderate risk Terminated Jul 21, 2023

Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279…

Reason cGMP deviations: Batch was released prior to approval.

Aurobindo Pharma USA Inc. NDC 59651-616-08 D-1087-2023

Class II · Moderate risk Terminated Jul 20, 2023

FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL…

Reason cGMP deviations: due to shipment of rejected units.

SCA Pharmaceuticals NDC 70004-0253-40 D-0945-2023

Class III · Low risk Terminated Jul 18, 2023

Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratories Ltd…

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

Ascend Laboratories, LLC NDC 67877-749-57 D-1145-2023

Class III · Low risk Terminated Jul 18, 2023

Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Survey No…

Reason Out of Specification result observed in content uniformity testing

Sun Pharmaceutical Industries INC NDC 47335-063-86 D-1082-2023

Class II · Moderate risk Terminated Jul 17, 2023

morphine in 0.9% Sodium Chloride, 50 mg/50 mL (1mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935…

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

Central Admixture Pharmacy Services Inc D-1080-2023

Class II · Moderate risk Terminated Jul 17, 2023

fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc…

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

Central Admixture Pharmacy Services Inc D-1079-2023

Class II · Moderate risk Terminated Jul 17, 2023

PHENYLephrine in 0.9 sodium chloride, 400 mcg /10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite…

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

Central Admixture Pharmacy Services Inc D-1078-2023

Class II · Moderate risk Terminated Jul 17, 2023

PHENYLephrine in 0.9 sodium chloride, 800 mcg /10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite…

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

Central Admixture Pharmacy Services Inc NDC 71286-6008-1 D-1077-2023

Class II · Moderate risk Terminated Jul 17, 2023

rocuronium, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite…

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

Central Admixture Pharmacy Services Inc D-1076-2023

Class II · Moderate risk Terminated Jul 17, 2023

midazolam in dextrose 5%, 50 mg /50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935…

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

Central Admixture Pharmacy Services Inc NDC 71286-4036-1 D-1075-2023

Class II · Moderate risk Terminated Jul 17, 2023

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…

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

Central Admixture Pharmacy Services Inc D-1074-2023

Class II · Moderate risk Terminated Jul 17, 2023

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…

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

Central Admixture Pharmacy Services Inc NDC 71286-6004-1 D-1073-2023

Class II · Moderate risk Terminated Jul 17, 2023

fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, bag…

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

Central Admixture Pharmacy Services Inc NDC 71286-2082-2 D-1072-2023

Class II · Moderate risk Terminated Jul 17, 2023

ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San…

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

Central Admixture Pharmacy Services Inc NDC 71286-3022-1 D-1071-2023

Class II · Moderate risk Terminated Jul 17, 2023

fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total Volume = 100 mL, Total FentaNYL 200 mcg/100 mL, 100…

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

Central Admixture Pharmacy Services Inc NDC 71286-2082-1 D-1070-2023

Class II · Moderate risk Terminated Jul 17, 2023

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…

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

Central Admixture Pharmacy Services Inc NDC 71286-2081-1 D-1069-2023

Class II · Moderate risk Terminated Jul 17, 2023

morphine in 0.9% sodium chloride, 125 mg/25 mL, (5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc…

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

Central Admixture Pharmacy Services Inc NDC 71286-2041-2 D-1068-2023

Class II · Moderate risk Terminated Jul 17, 2023

fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total Volume = 50 mL, Total fentaNYL 75 mcg/50 mL, 50 mL…

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

Central Admixture Pharmacy Services Inc NDC 71286-2080-2 D-1067-2023

Class II · Moderate risk Terminated Jul 17, 2023

PHENYLephrine in 0.9% sodium chloride, 1000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy Services…

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

Central Admixture Pharmacy Services Inc NDC 71286-6009-1 D-1066-2023

Class II · Moderate risk Terminated Jul 17, 2023

morphine in 0.9% sodium chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935…

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

Central Admixture Pharmacy Services Inc NDC 71286-2040-3 D-1065-2023

Class II · Moderate risk Terminated Jul 17, 2023

morphine in 0.9% sodium chloride, 1 mg/1 mL, (1 mg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935…

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

Central Admixture Pharmacy Services Inc NDC 71286-2040-1 D-1064-2023

Class II · Moderate risk Terminated Jul 17, 2023

fentaNYL in 0.9% sodium chloride, 5000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc…

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

Central Admixture Pharmacy Services Inc NDC 71286-2074-1 D-1063-2023

Class II · Moderate risk Terminated Jul 17, 2023

fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc…

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

Central Admixture Pharmacy Services Inc NDC 71286-2071-7 D-1062-2023