Recalls / Class II
Class IID-1154-2022
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
- Lot: HAC3427A, EXP Date: 08/2023
Why it was recalled
Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 47,500 vials
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2022-06-10
- FDA classified
- 2022-06-22
- Posted by FDA
- 2022-06-29
- Terminated
- 2023-07-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1154-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.