FDA-Drug2013-06-05Class II
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
Mylan Pharmaceuticals Inc.
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..
Sold states
Nationwide
Affected count
3,048 bottles
Manufactured in
781 Chestnut Ridge Rd, N/A, Morgantown, WV, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-500-2013Don't want to check this manually?
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