January 2018 FDA Recall Doxorubicin Hydrochloride by Sun Pharmaceutical Industries, Inc.
D-0229-2018 - Lack Of Assurance Of Sterility

This Class II drug recall was voluntarily initiated by Sun Pharmaceutical Industries, Inc. on January 16, 2018 for the product Doxorubicin Hydrochloride. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0229-2018

Reason for Recall
Lack Of Assurance Of Sterility
Initiated
01-16-2018
Reported
01-31-2018
Quantity
393 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78947
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sun Pharmaceutical Industries, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-14-2018
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# JKS0403A Exp 02/2019

Affected Packages Involved in this Recall

47335-049-40 Doxorubicin Hydrochloride
47335-050-40 Doxorubicin Hydrochloride