FDA-Drug2018-01-31Class II

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

Sun Pharmaceutical Industries, Inc.
Hazard

Lack Of Assurance Of Sterility

Sold states
Product was distributed nationwide in the USA
Affected count
393 vials
Manufactured in
270 Prospect Plains Rd, N/A, Cranbury, NJ, United States
Products
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

Official notice

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

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