Mylan Pharmaceuticals Inc. recalls Ropinirole hydrochloride tablets, USP 4 mg, 100-count bottle (NDC 0378-5504-01), Rx only, Manufactured for: Mylan Pharm

Recalled June 5, 2013 · FDA recall D-500-2013 · Mylan Pharmaceuticals

Hazard

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.. · FDA Class II

Units

3,048 bottles

Sold at

Nationwide

Description

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..

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

Manufacturer(s)

Mylan Pharmaceuticals Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →