April 2013 FDA Recall Drug by Mylan Pharmaceuticals Inc.
D-500-2013 - Labeling

This Class II drug recall was voluntarily initiated by Mylan Pharmaceuticals Inc. on April 22, 2013 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-500-2013

Reason for Recall
Labeling: Label Error on Declared Strength- Unopened bottles of Ropinirole USP 3 mg tablets was found to be incorrectly labeled as Ropinirole USP 4 mg tablets..
Initiated
04-22-2013
Reported
06-05-2013
Quantity
3,048 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65008
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-14-2014
Product Description About Product Description
Full technical description of the product.
Ropinirole hydrochloride tablets, USP 4 mg, 100-count bottle (NDC 0378-5504-01), Rx only, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. Made in India

Batch or Lot Expiration Information

Lot# ZRMB11004, Exp 09/13