The Recall Desk
ModerateFDA (Drugs)·D-0431-2023·Announced 2023-03-08

Ropinirole Tablets Recalled Due to Manufacturing Quality Violations

Accord Healthcare is recalling Ropinirole 5mg tablets due to Current Good Manufacturing Practice (CGMP) deviations identified during an FDA inspection. The recall affects 5,112 bottles distributed in the United States, Puerto Rico, and Canada.

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 is an FDA Class II precautionary recall due to CGMP deviations with no reported illnesses or injuries. Manufacturing quality violations without documented adverse events warrant a Moderate severity rating per the rubric.

Plain-English summary

Accord Healthcare, Inc. is recalling Ropinirole (ropinirole hydrochloride) 5mg tablets due to Current Good Manufacturing Practice (CGMP) deviations discovered during a U.S. Food and Drug Administration inspection.

The recall affects 5,112 bottles distributed across three batches: P2104150 and P2104151 (expiration 6/30/2023), and P2202065 (expiration 3/31/2024). The product was distributed to patients in the United States, Puerto Rico, and Canada.

Patients who have been dispensed ropinirole from the affected batches should contact their pharmacist or healthcare provider to discuss their medication. Patients should not stop taking their medication without consulting a healthcare professional, as abrupt discontinuation may cause harm. Verify the batch number on your medication bottle against the recalled batch numbers.

The recalled product

Product
ROPINIROLE (ROPINIROLE)
Brand
ROPINIROLE
Manufacturer
Accord Healthcare, Inc.
Category
Drug
Hazard
Affected units
5,112

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 (5)

  • Batches: P2104150
  • P2104151
  • Exp. Date 6/30/2023
  • P2202065
  • Exp. Date 3/31/2024

UPCs (1)

  • 316729238014

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 67 recalled by Accord Healthcare, 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.

See all 67 products in this recall →

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