Drug product
Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in Czech Republic by: Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Packaged and Distributed by: Major Pharmaceuticals Indianapolis, IN 46268 USA. NDC 0904-7257-61, UPC 3 09047 25761 4
D-0432-2023
Product summary
- Event
- Event 91751
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17,586 cartons
- Official record key
drug-enforcement:D-0432-2023
Official wording
Reason: Packaging defect: observed packaging defect, blister packaging inadequately sealed.
Code information: Lot: M04145 Exp. 01/2024
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Labeling or packaging
Packaging defect