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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