Recalls / Class II
Class IID-1146-2022
Product
medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Single-Dose Vial, 150 mg/mL, Rx only, Manufactured for: Northstart Rx LLC, Memphis, TN, 38141, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol Baroda Highway, Halol-389 350, Gujarat India , NDC 16714-981-01.
- Affected lot / code info
- Lot: HAC2075A, Exp 06/2023; HAC2076A, Exp 07/2023; HAC2077A, HAC2078A, Exp 08/2023; HAC3803A, Exp 09/2023; HAC0551A, Exp 02/2023; HAC0562A, HAC1183A, Exp 03/2023; HAC1807A, Exp 06/2023; JKX6017A, JKX6018A Exp 12/2022; HAC0163A, Exp 01/2023; HAC1184A, Exp 04/2023; HAC0162A, Exp 12/2022.
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
- 180813 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-1146-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.