July 2012 FDA Recall Levetiracetam by Mylan Pharmaceuticals Inc.
D-1702-2012 - Adulterated Presence of Foreign Tablets
This Class II drug recall was voluntarily initiated by Mylan Pharmaceuticals Inc. on July 27, 2012 for the product Levetiracetam. The FDA reported the reason for recall as adulterated presence of foreign tablets. The product was distributed in The product was distributed to KY. and the recall is currently terminated.
Recall Number: D-1702-2012
Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP 500 mg.
07-27-2012
10-03-2012
960 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
The product was distributed to KY.
05-21-2013
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Levetiracetam Tablets, USP 500 mg, 500 count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-5615-05
Batch or Lot Expiration Information
Lot# Lot ZLMM12063, Exp March 2014
