D-500-2013 Class II Terminated
FDA drug recall D-500-2013 was initiated by Mylan Pharmaceuticals Inc. on Apr 22, 2013 and is designated Class II. 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.. The recall status is terminated (terminated Apr 14, 2014). Affected quantity: 3,048 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Jun 5, 2013
- Initiation Date
- Apr 22, 2013
- Termination Date
- Apr 14, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,048 bottles
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
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 pattern
Nationwide
Code information
Lot # ZRMB11004, Exp 09/13
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-500-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026