Warfarin Sodium Tablet
FDA Recall NDC 51672-4030
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 Warfarin Sodium (NDC 51672-4030). A significant event, classified as Class III, was initiated on Aug 25, 2014 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Failed Content Uniformity Specifications."
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 III Terminated
Failed Content Uniformity Specifications.
Aug 25, 2014
Sep 24, 2014
1396 Bottles
Recall Profile & Regulatory Data
Event ID
69075
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Taro Pharmaceuticals U.S.A., Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States including: OH, HI, NH, MS, IL, TX, CA.
Termination Date
May 18, 2018
Product Description
Warfarin Sodium Tablets, USP Crystalline, 2 mg, 100 and 1000 Tablet Bottles, Rx Only. Mfd. by: Taro Pharmaceutical Industries, Ltd., Haifa Bay, Israel 26110. Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. 100 Tablet Bottle NDC: 51672-4028-1, 1000 Tablet Bottle NDC: 51672-4028-3.
Batch or Lot Expiration Information
Lot# : 149400, Expiry: January 2016
Lot# : 149649, Expiry: January 2016.
Affected Packages Involved in this Recall
51672-4027-1Product
51672-4027-3Product
51672-4027-7Product
51672-4027-0Product
51672-4028-1Product
51672-4028-3Product
51672-4028-7Product
51672-4028-0Product
51672-4029-1Product
51672-4029-3Product
51672-4029-7Product
51672-4029-0Product
51672-4030-1Product
51672-4030-3Product
51672-4030-7Product
51672-4030-0Product
51672-4031-1Product
51672-4031-3Product
51672-4031-7Product
51672-4031-0Product
51672-4032-1Product
51672-4032-3Product
51672-4032-7Product
51672-4032-0Product
51672-4033-1Product
51672-4033-3Product
51672-4033-7Product
51672-4033-0Product
51672-4034-1Product
51672-4034-3Product
51672-4034-0Product
51672-4035-1Product
51672-4035-3Product
51672-4035-0Product
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.
