D-0229-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 31, 2018
- Initiation Date
- January 16, 2018
- Termination Date
- September 14, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 393 vials
Product Description
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
Reason for Recall
Lack Of Assurance Of Sterility
Distribution Pattern
Product was distributed nationwide in the USA
Code Information
Lot # JKS0403A Exp 02/2019