Recall: D-0229-2018

Class II - Potentially Harmful

Class IIClassification

2018-01-16Initiated

TerminatedStatus

Sun Pharmaceutical Industries,Firm

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

Lack Of Assurance Of Sterility

Distribution

Product was distributed nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.