Drug recall D-1584-2014

Class III Terminated reported Sep 24, 2014

Product

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.

Lots and codes

Lot #: 149400, Expiry: January 2016; Lot #: 149649, Expiry: January 2016.

Recall details

Recalling firm
Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY
Quantity
1396 Bottles
Distribution
United States including: OH, HI, NH, MS, IL, TX, CA.
Type
Voluntary: Firm initiated
Recall initiated
August 25, 2014
Terminated
May 18, 2018

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