The Recall Desk
HighFDA (Drugs)·D-0494-2023·Announced 2023-04-12

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
  • manufacturing-deviation

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.

Related recalls

Same category