Ropinirole 0.5 mg tablets recalled for manufacturing quality deviations
RemedyRepack Inc. is recalling 17 bottles of Ropinirole 0.5 mg tablets due to manufacturing process deviations. The product was distributed nationwide within the United States.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II FDA recall of a prescription medication with no reported illnesses or injuries. Manufacturing process deviations represent a potential risk-of-harm situation even without yet-reported adverse events.
Plain-English summary
RemedyRepack Inc. is recalling 17 bottles of Ropinirole 0.5 mg tablets, packaged in 90-count bottles with NDC 70518-2439-00.
The affected lot numbers are B1789178-080122 (expiration date 07/31/2023) and B1675475-050522 (expiration date 05/31/2023). The product was distributed nationwide within the United States to consignees.
The recall was initiated on March 20, 2023, due to current Good Manufacturing Practice (cGMP) deviations in the manufacturing process. This is a voluntary recall initiated by the firm.
The recall was terminated on October 19, 2023.
The recalled product
- Product
- Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2439-00.
- Manufacturer
- RemedyRepack Inc.
- Category
- Drug — Parkinson's Medication
- Hazard
- Affected units
- 17
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 (4)
- Lot #: B1789178-080122
- Exp. Date 07/31/2023
- B1675475-050522
- Exp. Date 05/31/2023
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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