Drug product
DOXOrubicin Hydrochloride Liposome Injection, 20 mg/10 ml (2 mg/mL), 10 mL Single Use Vial, Distributed by: Sun Pharmaceutical Industries , Inc. Cranbury, NJ 08512. Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway. Halol-389 350, Gujarat, India. NDC 47335-049-40
D-0229-2018
Product summary
- Event
- Event 78947
- Status
- Terminated
- Classification
- Class II
- Quantity
- 393 vials
- Official record key
drug-enforcement:D-0229-2018
Official wording
Reason: Lack Of Assurance Of Sterility
Code information: Lot # JKS0403A Exp 02/2019
Distribution pattern: Product was distributed nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack Of Assurance Of Sterility