Recalls / Class II
Class IID-0494-2023
Product
Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2439-00.
- Affected lot / code info
- Lot #: B1789178-080122, Exp. Date 07/31/2023; B1675475-050522, Exp. Date 05/31/2023
Why it was recalled
cGMP Deviations
Recalling firm
- Firm
- RemedyRepack Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 625 Kolter Dr Ste 4, Indiana, Pennsylvania 15701-3571
Distribution
- Quantity
- 17 bottles
- Distribution pattern
- RemedyRepack distributed product to consignees nationwide within the United States
Timeline
- Recall initiated
- 2023-03-20
- FDA classified
- 2023-03-31
- Posted by FDA
- 2023-04-12
- Terminated
- 2023-10-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0494-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.