Status
Ongoing
Drug Enforcement D-057-2013
Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Classification
Class I
Report Date
November 28, 2012
Termination Date
—
Product Information
- Product description
- HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21
- Product quantity
- 14,445 bottles
- Reason for recall
- Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
- Recall initiation reason
- —
- Initial firm notification
- Press Release
- Distribution pattern
- Nationwide.
Location & Firm
- Recalling firm
- Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals
- Address
-
120 Vintage Dr NE, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-057-2013
- Event ID
- 63138
- Recall initiation date
- September 10, 2012
- Center classification date
- November 16, 2012
- Code info
- Lot number: C1440512A, Exp 12/13
- More code info
- —