FDA Recall D-838-2013
Zydus Pharmaceuticals USA Inc · Pennington, NJ
Class I — life-threatening Terminated 722 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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
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 record
- Recall number
D-838-2013- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide
- Recall initiated
- 2013-05-13
- Classified by FDA Center
- 2013-08-02
- FDA published
- 2013-08-14
- Terminated
- 2015-05-05
- Recalling firm
- Zydus Pharmaceuticals USA Inc
- Firm location
- Pennington, NJ