Drug recall D-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.
Reason for recall
Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
Lots and codes
Lot: HAC3427A, EXP Date: 08/2023
Recall details
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
- Quantity
- 47,500 vials
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 10, 2022
- Terminated
- July 25, 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.