June 2012 FDA Recall Drug by Mylan Pharmaceuticals Inc.
D-1703-2012 - Impurities/Degradation Products

This Class III drug recall was voluntarily initiated by Mylan Pharmaceuticals Inc. on June 28, 2012 for the product Drug. The FDA reported the reason for recall as impurities/degradation products. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1703-2012

Reason for Recall
Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing.
Initiated
06-28-2012
Reported
10-10-2012
Quantity
31,867 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62911
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 Pharmaceuticals Inc.
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 and PR
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-29-2013
Product Description About Product Description
Full technical description of the product.
Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-3020-01

Batch or Lot Expiration Information

Lot# Lot: 3018952, Exp 08/12