Drug product
Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For VersaPharm Incorporated, Maroerre, GA 30062. Mfg By: Swiss Caps AG, Kirchberg, Switzerland. NDC: 61748-025-01
D-1183-2018
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 80880
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23,788 100-count bottles
- Official record key
drug-enforcement:D-1183-2018
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.
Code information: Lots: 1165280100, 1165280101, EXP 3/2019
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of specification