Reported Jun 5, 2013 · Terminated
Ropinirole hydrochloride tablets, USP 4 mg, 100-count bottle (NDC 0378-5504-01), Rx only, Manufactured for: Mylan…
Mylan Pharmaceuticals Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mylan Pharmaceuticals Inc. · 781 Chestnut Ridge Rd · Morgantown, WV · 26505-2730
Is this the product you have?
- Ropinirole hydrochloride tablets, USP 4 mg, 100-count bottle (NDC 0378-5504-01), Rx only
- Manufactured forMylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. Made in India
- Lot codes and dates
Lot # ZRMB11004Exp 09/13
- Amount recalled
- 3,048 bottles
Where it was sold
- Nationwide
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..
This product could cause temporary or reversible health problems — stop using it.
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