FDA recall D-1584-2014

Taro Pharmaceuticals U.S.A., Inc. · Class III · drug

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.

Distribution

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

Key facts

Status: Terminated
Initiation date: 2014-08-25
Report date: 2014-09-24
Termination date: 2018-05-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: Hawthorne, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1584-2014