Status
Terminated
Drug Enforcement D-500-2013
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..
Classification
Class II
Report Date
June 5, 2013
Termination Date
April 14, 2014
Product Information
- Product description
- 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
- Product quantity
- 3,048 bottles
- 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..
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Address
-
781 Chestnut Ridge Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-500-2013
- Event ID
- 65008
- Recall initiation date
- April 22, 2013
- Center classification date
- May 30, 2013
- Code info
- Lot # ZRMB11004, Exp 09/13
- More code info
- —