Home / Recalls / Akorn, Inc. / D-1183-2018

D-1183-2018 Class II Terminated

Recalled by Akorn, Inc. — Lake Forest, IL

FDA drug recall D-1183-2018 was initiated by Akorn, Inc. on Aug 24, 2018 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity. The recall status is terminated (terminated Nov 6, 2020). Affected quantity: 23,788 100-count bottles.

Recall Details

Product Type: Drugs
Report Date: Sep 12, 2018
Initiation Date: Aug 24, 2018
Termination Date: Nov 6, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 23,788 100-count bottles

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.

Distribution Pattern

Nationwide in the USA

Code Information

Lots: 1165280100, 1165280101, EXP 3/2019

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1183-2018
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 24, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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