US Drug Recall Register
Class II · Moderate risk Terminated Initiated Apr 22, 2013 (13 years ago)

Ropinirole hydrochloride tablets

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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..

What was recalled

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

Recalling firm
Mylan Pharmaceuticals Inc.
NDC code
0378-5504-01
Origin
WV, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-500-2013

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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