FDA recall D-1183-2018

Akorn, Inc. · Class II · 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

Reason for recall

Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2018-08-24
Report date: 2018-09-12
Termination date: 2020-11-06
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1183-2018