Recalls / Class II
Class IID-1144-2022
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.
- Affected lot / code info
- Lot#: HAC1289A, Exo 06/2023; JKX2679A, Exp 06/2022; JKX3762A, Exp 08/2022; HAC0164A, Exp 06/2023.
Why it was recalled
Lack of assurance of sterility
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 57997 syringes
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2022-05-06
- FDA classified
- 2022-06-10
- Posted by FDA
- 2022-06-22
- Terminated
- 2023-08-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1144-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.