Drug product
medroxyPROGESTERone Acetate Injectable Suspension, USP, 25 x 1 mL Single-Dose Vial, 150 mg/mL, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol Baroda Highway, Halol-389 350, Gujarat India , NDC 16714-090-40 packaged in 25 count carton.
D-1147-2022
Product summary
- Event
- Event 90151
- Status
- Terminated
- Classification
- Class II
- Quantity
- 26892 vials
- Official record key
drug-enforcement:D-1147-2022
Official wording
Reason: Lack of assurance of sterility
Code information: Lot#: HAC2074A, Exp Date 06/2023; HAC0163B, Exp Date 01/2023 & HAC1741A, Exp Date 04/2023
Distribution pattern: USA Nationwide
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility