Drug recall D-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.
Reason for recall
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.
Lots and codes
HAC1974A, HAC1978A, Exp 06/2023
Recall details
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
- Quantity
- 97,450 vials
- Distribution
- Nationwide in the USA and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 3, 2022
- Terminated
- May 24, 2023
Related products
- Testosterone Cypionate – drug information
- NDC 62756-015 Testosterone Cypionate · Testosterone Cypionate 200 mg/mL · Sun Pharmaceutical Industries, Inc.
- NDC 62756-016 Testosterone Cypionate · Testosterone Cypionate 200 mg/mL · Sun Pharmaceutical Industries, Inc.
- NDC 62756-017 Testosterone Cypionate · Testosterone Cypionate 100 mg/mL · Sun Pharmaceutical Industries, Inc.