HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, M...
FDA Recall #D-057-2013 — Class I — September 10, 2012
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.
Recalling Firm
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals — Huntsville, AL
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
14,445 bottles
Distribution
Nationwide.
Code Information
Lot number: C1440512A, Exp 12/13
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated