FDAClass IIJanuary 31, 2018

DOXOrubicin Hydrochloride Liposome Injection recall: Sterility Concern

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

Why was DOXOrubicin Hydrochloride Liposome Injection recalled?

Lack Of Assurance Of Sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # JKS0403A Exp 02/2019

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
Recalling firm
Sun Pharmaceutical Industries, Inc.
Quantity
393 vials
Distribution
Product was distributed nationwide in the USA
Recall date
January 31, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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