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
Reported: June 5, 2013 Initiated: April 22, 2013 #D-500-2013
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..
Details
- Recalling Firm
- Mylan Pharmaceuticals Inc.
- Units Affected
- 3,048 bottles
- Distribution
- Nationwide
- Location
- Morgantown, WV
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Mylan Pharmaceuticals Inc.. Units affected: 3,048 bottles.
Why was this product 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..
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 5, 2013. Severity: Moderate. Recall number: D-500-2013.
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