December 2012 FDA Recall Drug by Mylan Institutional, Inc. (d.b.a. Udl Laboratories) (D-166-2013 - Superpotent (Multiple Ingredient) Drug)

This Class I drug recall was voluntarily initiated by Mylan Institutional, Inc. (d.b.a. Udl Laboratories) on December 14, 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 terminated.

Recall Number: D-166-2013

Reason for Recall
Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Initiated
12-14-2012
Reported
02-27-2013
Quantity
3,407 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63899
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-09-2016
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# : 3037841, 3040859, 3042573, Exp 12/13