Ropinirole tablets recalled due to manufacturing practice deviations
Accord Healthcare is recalling Ropinirole 1 mg tablets due to manufacturing deviations identified during FDA inspection. No illnesses have been reported.
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 recall for manufacturing process deviations. CGMP violations represent a risk-of-harm to patients, but no illnesses or injuries have been reported. The specific manufacturing defect is not disclosed.
Plain-English summary
Accord Healthcare, Inc. is recalling Ropinirole tablets (1 mg) distributed in the United States, Puerto Rico, and Canada. Approximately 104,945 bottles are affected across multiple production batches with expiration dates ranging from May 2023 to May 2024.
The recall was issued following an FDA inspection that identified deviations from Current Good Manufacturing Practices (CGMP). CGMP deviations indicate the manufacturing process did not meet federal standards, though the specific nature of the deviation has not been publicly disclosed.
Patients should consult their healthcare provider before stopping or changing their medication. Healthcare providers and pharmacists should verify whether specific batches are affected and advise patients accordingly. Consumers with affected bottles should return them to their pharmacy.
The recalled product
- Product
- ROPINIROLE (ROPINIROLE)
- Brand
- ROPINIROLE
- Manufacturer
- Accord Healthcare, Inc.
- 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 (14)
- Batches: P2103544 Exp. Date 5/31/2023
- P2106132
- P2106131
- P2106128
- P2106129
- P2106130
- P2106133
- Exp. Date 8/31/2023
- P2107662
- P2107663
- P2107664
- Exp. Date 11/30/2023
- P2203543
- Exp. Date 5/31/2024
UPCs (1)
- 316729234016
Distribution
Distribution scope not specified by the agency.
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