Drug recall D-0229-2018

Class II Terminated reported Jan 31, 2018

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

Reason for recall

Lack Of Assurance Of Sterility

Lots and codes

Lot # JKS0403A Exp 02/2019

Recall details

Recalling firm
Sun Pharmaceutical Industries, Inc., Cranbury, NJ
Quantity
393 vials
Distribution
Product was distributed nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
January 16, 2018
Terminated
September 14, 2018

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