The Recall Desk
ModerateFDA (Drugs)·D-0499-2023·Announced 2023-04-12

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
  • 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 (2)

  • Lot#: B1630017-040122
  • Exp. Date 04/30/2023

Distribution

Distributed nationwide across the United States.

Related recalls

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