Why it was recalled
Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were oversized.
Product description
Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-053-10
Lot numbers, UPCs & expiration codes
Lot MM5767
Where it was sold
Nationwide
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-838-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 13, 2013
- FDA report date
- Aug 14, 2013
- Quantity
- 960 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals USA Inc
Original FDA data
Every field from FDA enforcement report D-838-2013, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 65394
- Address
- 73 Route 31 N
- Code information
- Lot MM5767
- Postal code
- 08534-3601
- Report date
- Aug 14, 2013
- Product type
- Drugs
- Recall number
- D-838-2013
- Classification
- Class I
- Recalling firm
- Zydus Pharmaceuticals USA Inc
- Product quantity
- 960 Bottles
- Termination date
- May 5, 2015
- Reason for recall
- Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were oversized.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-053-10
- Distribution pattern
- Nationwide
- Recall initiation date
- May 13, 2013
- Initial firm notification
- Letter
- Center classification date
- Aug 2, 2013