Recalls / Class II
Class IID-1147-2022
Product
medroxyPROGESTERone Acetate Injectable Suspension, USP, 25 x 1 mL Single-Dose Vial, 150 mg/mL, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol Baroda Highway, Halol-389 350, Gujarat India , NDC 16714-090-40 packaged in 25 count carton.
- Affected lot / code info
- Lot#: HAC2074A, Exp Date 06/2023; HAC0163B, Exp Date 01/2023 & HAC1741A, Exp Date 04/2023
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
- 26892 vials
- 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-1147-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.