Ropinirole Tablets Recalled by Accord Healthcare Following FDA Inspection
Accord Healthcare is recalling 25,344 bottles of Ropinirole 2 mg tablets due to manufacturing deviations discovered during an FDA inspection. The recall affects medications 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: FDA Class II precautionary recall due to manufacturing deviations with no reported illnesses or injuries. Per the rubric, theoretical hazards without reported harm score at most 3; this precautionary manufacturing recall falls within the Moderate category.
Plain-English summary
Accord Healthcare, Inc. is recalling 25,344 bottles of Ropinirole Tablets USP 2 mg due to Current Good Manufacturing Practice (CGMP) deviations discovered during an FDA inspection. The medication was manufactured by Intas Pharmaceuticals Limited and distributed in the United States, Puerto Rico, and Canada.
The affected product carries NDC number 16729-235-01 and includes the following batches: P2106370 and P2106369 (expiration date 9/30/2023), and batch P2201254 (expiration date 2/29/2024). Consumers should verify their medication against these batch numbers and expiration dates.
Patients currently taking Ropinirole should contact their healthcare provider or pharmacist to determine whether their medication is affected by this recall and to discuss next steps. The FDA has classified this as a Class II recall.
The recalled product
- Product
- ROPINIROLE (ROPINIROLE)
- Brand
- ROPINIROLE
- Manufacturer
- Accord Healthcare, 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 (5)
- Batches: P2106370
- P2106369
- Exp. Date 9/30/2023
- P2201254
- Exp. Date 2/29/2024
UPCs (1)
- 316729235013
Distribution
Distribution scope not specified by the agency.
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