Drug recall D-1176-2022
Product
Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose vial, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40.
Reason for recall
CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.
Lots and codes
Lots JKX3267A & JKX3686A Exp. Date 08/2022 Lot JKX4700A, Exp Date 10/2022 Lot JKX5727A, Exp date 11/2022
Recall details
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
- Quantity
- 27 vials
- Distribution
- nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 3, 2022
- Terminated
- May 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.