Drug product
medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India Distributed by: Afaxys Pharma, LLC, Charleston, SC, 29403, USA, Product of Italy, NDC 50102-591-40.
D-1143-2022
Product summary
- Event
- Event 90151
- Status
- Terminated
- Classification
- Class II
- Quantity
- 79339 syringes
- Official record key
drug-enforcement:D-1143-2022
Official wording
Reason: Lack of assurance of sterility
Code information: Lots#: JKX4312A & JKX4313A, Exp 09/2022; JKX4827A, Exp 09/2023; HAC1290A & HAC2082B, Exp 06/2023;
Distribution pattern: USA Nationwide
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility