Ropinirole 2mg Tablets Recalled for Manufacturing Practice Deviations
RemedyRepack Inc. is recalling Ropinirole 2mg tablets due to manufacturing practice deviations. No illnesses have been reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This voluntary recall with no reported illnesses fits the rubric for Moderate (2): a precautionary recall for manufacturing process deviations without specific identified hazards or reported adverse effects.
Plain-English summary
RemedyRepack Inc. is recalling Ropinirole 2mg tablets packaged in 180-count bottles. The recalled product includes 3 bottles with Lot Number B1630017-040122 and an expiration date of April 30, 2023. The medication was distributed nationwide in the United States.
The recall was initiated due to current good manufacturing practice (cGMP) deviations. RemedyRepack voluntarily initiated the recall in March 2023, and the FDA classified it as a Class II recall.
The recall was terminated on October 19, 2023. No illnesses or adverse effects have been reported.
The recalled product
- Product
- Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC70518-2750-00
- Manufacturer
- RemedyRepack Inc.
- Category
- Drug
- Hazard
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot#: B1630017-040122
- Exp. Date 04/30/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 recalled by RemedyRepack Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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