Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL bottles, Rx Only, Distributed by: Akorn O...
FDA Recall #D-0834-2023 — Class II — April 26, 2023
Product Description
Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, 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