Ropinirole Tablets Recalled for Manufacturing Practice Deviations
Accord Healthcare recalls 181,848 bottles of Ropinirole 0.5 mg tablets distributed in the U.S., Canada, and Puerto Rico due to manufacturing practice deviations identified during an FDA inspection.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is related to manufacturing deviations without specific product defect or reported harm, consistent with a Moderate severity classification.
Plain-English summary
Accord Healthcare, Inc. is recalling 181,848 bottles of Ropinirole 0.5 mg tablets distributed in the United States, including Puerto Rico, and Canada. The recall affects multiple batches with expiration dates ranging from March 31, 2023 through May 31, 2024.
An FDA inspection identified Current Good Manufacturing Practice (CGMP) deviations in the manufacturing process, prompting this Class II recall. The specific affected batches and their expiration dates are listed on the FDA's recall notice.
Ropinirole is a prescription medication used to treat Parkinson's disease and restless leg syndrome. Patients who believe they have affected bottles should contact their healthcare provider or pharmacist for guidance about their medication.
More information about this recall, including the complete list of affected batch numbers, is available on the FDA's official drug recall website.
The recalled product
- Product
- ROPINIROLE (ROPINIROLE)
- Brand
- ROPINIROLE
- Manufacturer
- Accord Healthcare, Inc.
- Category
- Drug
- Hazard
- cgmp-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 (20)
- Batches: P2102133
- P2102135
- P2102136
- Exp. Date 3/31/2023
- P2104998
- P2104997
- P2104991
- P2104992
- P2104990
- P2104993
- P2105000
- P2104999
- P2105002
- P2105001
- Exp. Date 7/31/2023
- P2106812
- Exp. Date
- 9/30/2023
- P2200433
- P2200434
UPCs (1)
- 316729233019
Distribution
Distribution scope not specified by the agency.
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