Class II · Moderate risk Ongoing
Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only…
Reason Lack of Assurance of Sterility.
FDA Drug Recalls
723 recalls, newest first
Class I · High risk Ongoing
SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China
Reason Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
Class II · Moderate risk Ongoing
NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals…
Reason Failed Dissolution Specifications
Class III · Low risk Ongoing
Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded drug, Office Use Only…
Reason Subpotent Drug
Class II · Moderate risk Ongoing
Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO TAB…
Reason Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine…
Class II · Moderate risk Ongoing
Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx only, Distributed by American Health Packaging…
Reason Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA)…
Class II · Moderate risk Ongoing
Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging…
Reason Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA)…
Class II · Moderate risk Ongoing
Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging…
Reason Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA)…
Class II · Moderate risk Ongoing
Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL), 2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Testosterone / Triamcinolone Acetonide Pellet (200MG/40MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio…
Reason CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk Ongoing
Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio…
Reason CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk Ongoing
Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio…
Reason CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk Ongoing
Testosterone / Triamcinolone Acetonide, 62.5MG/12.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio…
Reason CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk Ongoing
Testosterone / Triamcinolone Acetonide 50MG/10MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing…
Reason CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk Ongoing
Testosterone / Triamcinolone Acetonide Pellet (37.5MG/7.5MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio…
Reason CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk Ongoing
Testosterone / Triamcinolone Acetonide 25MG/5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing…
Reason CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk Ongoing
Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio…
Reason CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk Ongoing
Testosterone Regular Release 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball…
Reason CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk Ongoing
Testosterone Regular Release 50 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball…
Reason CGMP Deviations: Potential presence of metal particulate matter