FDAClass IIApril 12, 2023

Ropinirole 0.5 mg tablets recall: CGMP Deviations

Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2439-00.

Why was Ropinirole 0.5 mg tablets recalled?

cGMP Deviations

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: B1789178-080122, Exp. Date 07/31/2023; B1675475-050522, Exp. Date 05/31/2023

Product
Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2439-00.
Recalling firm
RemedyRepack Inc.
Quantity
17 bottles
Distribution
RemedyRepack distributed product to consignees nationwide within the United States
Recall date
April 12, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls