Drug product
Carbidopa and Levodopa Tablets USP, 25mg/100mg, 1000 count bottle, Rx only, Manufactured in Israel by Teva Pharmaceutical IND, LTD., Jeruselem, Israel, for Teva Pharmaceuticals USA, Sellersville, PA, NDC 0093-0293-10
D-1538-2014
Product summary
- Event
- Event 68522
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3881bottles
- Official record key
drug-enforcement:D-1538-2014
Official wording
Reason: Failed Tablet/Capsule Specifications: Teva is recalling one lot of Carbidopa and Levodopa Tablets USP, 25mg/100mg due to the potential for superpotent tablets.
Code information: lot 29C220, Exp. 11/15
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
superpotent