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Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by: Akorn, Inc., ...

FDA Recall #D-0816-2023 — Class II — April 26, 2023

Recall #D-0816-2023 Date: April 26, 2023 Classification: Class II Status: Ongoing

Product Description

Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs

Reason for Recall

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Recalling Firm

Akorn, Inc. — Gurnee, IL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

N/A

Distribution

Nationwide in the USA and Puerto Rico

Code Information

All Lots

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

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