Recalls / Class II
Class IID-1143-2022
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.
- Affected lot / code info
- Lots#: JKX4312A & JKX4313A, Exp 09/2022; JKX4827A, Exp 09/2023; HAC1290A & HAC2082B, 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
- 79339 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-1143-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.