August 2014 FDA Recall Warfarin Sodium by Taro Pharmaceuticals U.s.a., Inc.
D-1584-2014 - Failed Content Uniformity Specifications.
This Class III drug recall was voluntarily initiated by Taro Pharmaceuticals U.s.a., Inc. on August 25, 2014 for the product Warfarin Sodium. The FDA reported the reason for recall as failed content uniformity specifications.. The product was distributed in United States including: OH, HI, NH, MS, IL, TX, CA. and the recall is currently terminated.
Recall Number: D-1584-2014
Failed Content Uniformity Specifications.
08-25-2014
09-24-2014
1396 Bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Taro Pharmaceuticals U.S.A., Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
United States including: OH, HI, NH, MS, IL, TX, CA.
05-18-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# : 149400, Expiry: January 2016
Lot# : 149649, Expiry: January 2016.
