The Recall Desk
HighFDA (Drugs)·D-0479-2023·Announced 2023-04-05

Ropinirole 1 mg Tablets Recalled Nationwide for Manufacturing Process Deviations

Direct Rx is recalling Ropinirole 1 mg tablets nationwide due to manufacturing process deviations. Consult a pharmacist before stopping this medication.

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: FDA Class II classification with manufacturing process deviations. No illnesses or injuries are reported in the source, making the hazard theoretical. This meets the rubric criterion for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Direct Rx is recalling Ropinirole, USP, 1 mg tablets nationwide. The affected product is lot 22JU2216 (expiration 8/31/23), packaged in 30-count bottles with NDC 72189-0364-30. Four bottles of this lot were distributed nationwide.

The recall was initiated due to current good manufacturing practice (cGMP) deviations. The firm voluntarily initiated the recall on March 13, 2023, and it was terminated on June 17, 2024.

Patients taking this medication should not stop treatment without consulting their healthcare provider or pharmacist. If you have this medication, contact your pharmacy or healthcare provider for guidance on how to proceed.

The recalled product

Product
Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Manufacturer
Direct Rx
Category
Drug
Hazard
  • manufacturing-defect

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 (3)

  • Lot
  • expiry: 22JU2216
  • exp 8/31/23

Distribution

Distributed nationwide across the United States.

Related recalls

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