Drug 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
D-500-2013
Product summary
- Event
- Event 65008
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,048 bottles
- Official record key
drug-enforcement:D-500-2013
Official wording
Reason: 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..
Code information: Lot # ZRMB11004, Exp 09/13
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Label Error