Status
Terminated
Drug Enforcement D-838-2013
Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were oversized.
Classification
Class I
Report Date
August 14, 2013
Termination Date
May 5, 2015
Product Information
- 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
- Product quantity
- 960 Bottles
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Zydus Pharmaceuticals USA Inc
- Address
-
73 Route 31 N, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-838-2013
- Event ID
- 65394
- Recall initiation date
- May 13, 2013
- Center classification date
- August 2, 2013
- Code info
- Lot MM5767
- More code info
- —