PlainRecordsFDA · Drug recall
DOXOrubicin Hydrochloride Liposome Injection…
- Date
- Jan. 31, 2018
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Terminated
- Filed by
- Sun Pharmaceutical Industries, Inc.
- 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 pattern
- Product was distributed nationwide in the USA
- Quantity
- 393 vials
- Codes and lots
- Lot # JKS0403A Exp 02/2019
- Recall started
- Jan. 16, 2018
- Recall number
- D-0229-2018
What should I do? Medicine recall: what to do
Source: FDA · Drug enforcement report, recall number D-0229-2018. The agency record governs; check it and the company before acting.