Recalls / Class II
Class IID-500-2013
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
- Affected lot / code info
- Lot # ZRMB11004, Exp 09/13
Why it was recalled
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..
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, N/A, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 3,048 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-04-22
- FDA classified
- 2013-05-30
- Posted by FDA
- 2013-06-05
- Terminated
- 2014-04-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-500-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.