Status
Terminated
Drug Enforcement D-166-2013
Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Classification
Class I
Report Date
February 27, 2013
Termination Date
August 9, 2016
Product Information
- Product description
- Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg; 100 Tablets (5 x 20), 5 cards each containing 20 blistered tablets per carton, Rx only; Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, Pkg by & Distributed by UDL Laboratories, Inc., Rockford, IL 61103; NDC 51079-254-21.
- Product quantity
- 3,407 cartons
- Reason for recall
- Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Address
-
1718 Northrock Ct, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-166-2013
- Event ID
- 63899
- Recall initiation date
- December 14, 2012
- Center classification date
- February 15, 2013
- Code info
- Lot #: 3037841, 3040859, 3042573, Exp 12/13
- More code info
- —