Drug product
medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 16714-999-01.
D-1144-2022
Product summary
- Event
- Event 90151
- Status
- Terminated
- Classification
- Class II
- Quantity
- 57997 syringes
- Official record key
drug-enforcement:D-1144-2022
Official wording
Reason: Lack of assurance of sterility
Code information: Lot#: HAC1289A, Exo 06/2023; JKX2679A, Exp 06/2022; JKX3762A, Exp 08/2022; HAC0164A, Exp 06/2023.
Distribution pattern: USA Nationwide
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility