January 2014 FDA Recall Drug by Mylan Institutional, Inc. (d.b.a. Udl Laboratories) (D-1155-2014 - Failed Impurity/degradation Specification)

This Class III drug recall was voluntarily initiated by Mylan Institutional, Inc. (d.b.a. Udl Laboratories) on January 28, 2014 for the product Drug. The FDA reported the reason for recall as failed impurity/degradation specification. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1155-2014

Reason for Recall
Failed Impurity/degradation Specification
Initiated
01-28-2014
Reported
03-19-2014
Quantity
3,252 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67393
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
US: Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-19-2015
Product Description About Product Description
Full technical description of the product.
Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets (10 cards of 10 tablets each), Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL NDC 51079-819-20

Batch or Lot Expiration Information

Lot# Lots and Expiration Dates: 3037463, Expires 2/2014; 3039466, Expires 3/2014; 3040644, Expires 4/2014; 3043463, Expires 6/2014; 3049568, Expires 3/2015