PlainRecalls
FDA Drug Low Class III Terminated

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.

Reported: September 24, 2014 Initiated: August 25, 2014 #D-1584-2014

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.

Reason for Recall

Failed Content Uniformity Specifications.

Details

Units Affected
1396 Bottles
Distribution
United States including: OH, HI, NH, MS, IL, TX, CA.
Location
Hawthorne, NY

Frequently Asked Questions

What product was recalled?
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.. Recalled by Taro Pharmaceuticals U.S.A., Inc.. Units affected: 1396 Bottles.
Why was this product recalled?
Failed Content Uniformity Specifications.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 24, 2014. Severity: Low. Recall number: D-1584-2014.