FDAClass IISeptember 12, 2018

Ethosuximide Capsules recall: Impurity Out of Spec

Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For VersaPharm Incorporated, Maroerre, GA 30062. Mfg By: Swiss Caps AG…

Why was Ethosuximide Capsules recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lots: 1165280100, 1165280101, EXP 3/2019

Product
Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For VersaPharm Incorporated, Maroerre, GA 30062. Mfg By: Swiss Caps AG…
Recalling firm
Akorn, Inc.
Quantity
23,788 100-count bottles
Distribution
Nationwide in the USA
Recall date
September 12, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls