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: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 62756-091-40.
D-1145-2022
Product summary
- Event
- Event 90151
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4625 syringes
- Official record key
drug-enforcement:D-1145-2022
Official wording
Reason: Lack of assurance of sterility
Code information: Lot #: HAC1951A, Exp 06/2023
Distribution pattern: USA Nationwide
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility