Status
Terminated
Drug Enforcement D-058-2013
Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.
Classification
Class I
Report Date
November 28, 2012
Termination Date
March 24, 2014
Product Information
- Product description
- 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.
- Product quantity
- 4,874 bottles
- Reason for recall
- Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.
- Recall initiation reason
- —
- Initial firm notification
- Press Release
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Watson Laboratories Inc
- Address
-
311 Bonnie Cir, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-058-2013
- Event ID
- 63246
- Recall initiation date
- September 21, 2012
- Center classification date
- November 16, 2012
- Code info
- Lot #: 519406A, 521759A, Exp 04/14
- More code info
- —