Drug 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.
D-1176-2022
Product summary
- Event
- Event 90412
- Status
- Terminated
- Classification
- Class II
- Quantity
- 27 vials
- Official record key
drug-enforcement:D-1176-2022
Official wording
Reason: CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.
Code information: Lots JKX3267A & JKX3686A Exp. Date 08/2022 Lot JKX4700A, Exp Date 10/2022 Lot JKX5727A, Exp date 11/2022
Distribution pattern: nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations: Manufacturing deviations