Product Detail

Product Description 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

Recall Number D-500-2013

Classification Class II

Code Info Lot # ZRMB11004, Exp 09/13

Product Distributed Qty 3,048 bottles

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.

Event Detail

Event Id 65008

Product Type Drugs

Status Ongoing

Recalling Firm
Mylan Pharmaceuticals Inc.
City Morgantown

State WV
Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-04-22

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern Nationwide