Doxorubicin Hydrochloride Injectable, Liposomal
FDA Recall NDC 47335-049
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Doxorubicin Hydrochloride (NDC 47335-049). A significant event, classified as Class II, was initiated on Jan 16, 2018 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Lack Of Assurance Of Sterility"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Lack Of Assurance Of Sterility
Jan 16, 2018
Jan 31, 2018
393 vials
Recall Profile & Regulatory Data
Event ID
78947
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Sun Pharmaceutical Industries, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide in the USA
Termination Date
Sep 14, 2018
Product Description
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
47335-049-40Product
47335-050-40Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
