FDA Recall D-058-2013
Watson Laboratories Inc · Corona, CA
Class I — life-threatening Terminated 549 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 00591-0540-05.
Reason for recall
Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.
Recall record
- Recall number
D-058-2013- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide
- Recall initiated
- 2012-09-21
- Classified by FDA Center
- 2012-11-16
- FDA published
- 2012-11-28
- Terminated
- 2014-03-24
- Recalling firm
- Watson Laboratories Inc
- Firm location
- Corona, CA