drugs Class II Updated 2013-06-05

Mylan Pharmaceuticals Inc. recalls Ropinirole hydrochloride tablets, USP 4 mg, 100-count bottle

Recalled 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

Hazard / Issue

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..

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot # ZRMB11004, Exp 09/13
View official government recall

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