Drug & medication recalls Moderate risk

DOXOrubicin Hydrochloride Liposome Injection recalled over sterility concerns

Recall date
January 16, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Sun Pharmaceutical Industries, Inc. recalls DOXOrubicin Hydrochloride Liposome Injection, 20 mg/10 ml (2 mg/mL), 10 mL Single Use Vial, Distributed by: Sun Pharmac…
Recall number
D-0229-2018
FDA classification
Class II
Brand / firm
Sun Pharmaceutical Industries, Inc.
Sold / distributed
Product was distributed nationwide in the USA

Why it was recalled

Lack Of Assurance Of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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