Recalls / Class I
Class ID-058-2013
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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.
- Affected lot / code info
- Lot #: 519406A, 521759A, Exp 04/14
Why it was recalled
Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.
Recalling firm
- Firm
- Watson Laboratories Inc
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 311 Bonnie Cir, N/A, Corona, California 92880-2882
Distribution
- Quantity
- 4,874 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-09-21
- FDA classified
- 2012-11-16
- Posted by FDA
- 2012-11-28
- Terminated
- 2014-03-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-058-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.