Drug product
Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayne Pharma, Greenville, NC 27834. NDC 51862-858-01
D-0998-2020
Product summary
- Firm
- Mayne Pharma Inc
- Event
- Event 85125
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8274 100-count bottles
- Official record key
drug-enforcement:D-0998-2020
Official wording
Reason: Product Mix-Up: A foreign tablet was found in bottle.
Code information: Lot: FG11514 Exp. 05/2021
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
foreign tablet