September 2012 FDA Recall Drug by Vintage Pharmaceuticals Llc Dba Qualitest Pharmaceuticals (D-057-2013 - Superpotent (Multiple Ingredient) Drug)

This Class I drug recall was voluntarily initiated by Vintage Pharmaceuticals Llc Dba Qualitest Pharmaceuticals on September 10, 2012 for the product Drug. The FDA reported the reason for recall as superpotent (multiple ingredient) drug. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-057-2013

Reason for Recall
Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Initiated
09-10-2012
Reported
11-28-2012
Quantity
14,445 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63138
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# Lot number: C1440512A, Exp 12/13