FDA recall D-0229-2018

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

Distribution

Product was distributed nationwide in the USA

Key facts

Status

Terminated

Initiation date

2018-01-16

Report date

2018-01-31

Termination date

2018-09-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cranbury, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0229-2018