D-057-2013 Class I Ongoing
FDA drug recall D-057-2013 was initiated by Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals on September 10, 2012 and is designated Class I. Reason for recall: Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components. The recall status is ongoing. Affected quantity: 14,445 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- November 28, 2012
- Initiation Date
- September 10, 2012
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,445 bottles
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
Reason for Recall
Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Distribution Pattern
Nationwide.
Code Information
Lot number: C1440512A, Exp 12/13