Key Takeaway

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 by Mylan Pharmaceuticals Inc. was recalled on April 22, 2013. The hazard: 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...

FDA Drug Class II Terminated

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: April 22, 2013 ~3,048 bottles units affected D-500-2013

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

Hazard / Reason

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..

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

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

Drugs

Company Information

Mylan Pharmaceuticals Inc.

Morgantown, WV, United States

View all 79 recalls by Mylan Pharmaceuticals Inc. →

Distribution

Nationwide

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Frequently Asked Questions

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Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.