Recalls / Class II
Class IID-1153-2022
Product
Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, 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 62756-015-40.
- Brand name
- Testosterone Cypionate
- Generic name
- Testosterone Cypionate
- Active ingredient
- Testosterone Cypionate
- Route
- Intramuscular
- NDCs
- 62756-015, 62756-017, 62756-016
- FDA application
- ANDA201720
- Affected lot / code info
- HAC1974A, HAC1978A, Exp 06/2023
Why it was recalled
CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.
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
- 97,450 vials
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2022-06-03
- FDA classified
- 2022-06-21
- Posted by FDA
- 2022-06-29
- Terminated
- 2023-05-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1153-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.