Drug & medication recalls Moderate risk

Akorn, Inc. recalls Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For VersaPharm Incorporated, Maroerre, GA 300…

Recall date
August 24, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-1183-2018
FDA classification
Class II
Brand / firm
Akorn, Inc.
Sold / distributed
Nationwide in the USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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

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