Recall: D-1584-2014

Class III - Minor Violations

Class IIIClassification

2014-08-25Initiated

TerminatedStatus

Taro Pharmaceuticals U.S.A., IFirm

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

Failed Content Uniformity Specifications.

Distribution

United States including: OH, HI, NH, MS, IL, TX, CA.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.