Recalls / Class II
Class IID-1145-2022
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: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 62756-091-40.
- Brand name
- Medroxyprogesterone Acetate
- Generic name
- Medroxyprogesterone Acetate
- Active ingredient
- Medroxyprogesterone Acetate
- Route
- Intramuscular
- NDC
- 62756-091
- FDA application
- ANDA210761
- Affected lot / code info
- Lot #: HAC1951A, Exp 06/2023
Why it was recalled
Lack of assurance of sterility
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 4625 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-1145-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.