November 2015 FDA Recall Drug by Mylan Institutional, Inc. (d.b.a. Udl Laboratories) (D-0235-2016 - Failed Impurities/Degradation Specifications)

This Class III drug recall was voluntarily initiated by Mylan Institutional, Inc. (d.b.a. Udl Laboratories) on November 2, 2015 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0235-2016

Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Initiated
11-02-2015
Reported
11-25-2015
Quantity
4,609 Packages

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72595
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 including Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-21-2016
Product Description About Product Description
Full technical description of the product.
Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tablet Blister Pack Packages, Rx Only. Manufactured by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977. Mylan. NDC: 51079-090-20.

Batch or Lot Expiration Information

Lot# : 3060153, Expiry: 08/31/16