PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: September 12, 2018 Initiated: August 24, 2018 #D-1183-2018

Product Description

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.

Details

Recalling Firm
Akorn, Inc.
Units Affected
23,788 100-count bottles
Distribution
Nationwide in the USA
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by Akorn, Inc.. Units affected: 23,788 100-count bottles.
Why was this product recalled?
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 12, 2018. Severity: Moderate. Recall number: D-1183-2018.