Class II
Terminated
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
This recall has been terminated (originally issued June 5, 2013).
- Company
- Mylan Pharmaceuticals Inc.
- Recall Initiated
- April 22, 2013
- Posted
- June 5, 2013
- Recall Number
- D-500-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3,048 bottles
- Firm Location
- Morgantown, WV, United States
- Official Source
- View on FDA website ↗
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..
Distribution
Nationwide
Lot / Code Info
Lot # ZRMB11004, Exp 09/13
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