FDA Recall Carbidopa And Levodopa

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The last Recall Enforcement Report for Carbidopa And Levodopa with NDC 51862-855 was initiated on 03-15-2021 as a Class II recall due to cgmp deviations: intermittent exposure to temperature excursion during storage. The latest recall number for this product is D-0520-2021 and the recall is currently completed .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-0520-202103-15-202106-02-2021Class II407 BOXESCARBIDOPA AND LEVORDOPA TABLETS, USP 25MG/100MG 100 TABLETS; NDC/UPC 51862-856-01; RX; TABLETSCompleted
D-0998-202003-02-202003-18-2020Class II8274 100-count bottlesCarbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayne Pharma, Greenville, NC 27834. NDC 51862-858-01Terminated

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.