Recalls / Class III
Class IIID-1584-2014
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.
- Brand name
- Warfarin Sodium
- Generic name
- Warfarin Sodium
- Active ingredient
- Warfarin Sodium
- Route
- Oral
- NDCs
- 51672-4027, 51672-4028, 51672-4029, 51672-4030, 51672-4031, 51672-4032, 51672-4033, 51672-4034, 51672-4035
- FDA application
- ANDA040301
- Affected lot / code info
- Lot #: 149400, Expiry: January 2016; Lot #: 149649, Expiry: January 2016.
Why it was recalled
Failed Content Uniformity Specifications.
Recalling firm
- Firm
- Taro Pharmaceuticals U.S.A., Inc.
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Skyline Dr, N/A, Hawthorne, New York 10532-2174
Distribution
- Quantity
- 1396 Bottles
- Distribution pattern
- United States including: OH, HI, NH, MS, IL, TX, CA.
Timeline
- Recall initiated
- 2014-08-25
- FDA classified
- 2014-09-12
- Posted by FDA
- 2014-09-24
- Terminated
- 2018-05-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1584-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.