Why it was recalled
Failed Content Uniformity Specifications.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 149400, Expiry: January 2016; Lot #: 149649, Expiry: January 2016.
Where it was sold
United States including: OH, HI, NH, MS, IL, TX, CA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1584-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 25, 2014
- FDA report date
- Sep 24, 2014
- Quantity
- 1396 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
Original FDA data
Every field from FDA enforcement report D-1584-2014, exactly as published.
Show all FDA fields
- City
- Hawthorne
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 69075
- Address
- 3 Skyline Dr
- Code information
- Lot #: 149400, Expiry: January 2016; Lot #: 149649, Expiry: January 2016.
- Postal code
- 10532-2174
- Report date
- Sep 24, 2014
- Product type
- Drugs
- Recall number
- D-1584-2014
- Classification
- Class III
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- Product quantity
- 1396 Bottles
- Termination date
- May 18, 2018
- Reason for recall
- Failed Content Uniformity Specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- United States including: OH, HI, NH, MS, IL, TX, CA.
- Recall initiation date
- Aug 25, 2014
- Initial firm notification
- Letter
- Center classification date
- Sep 12, 2014