FDA Drug Moderate Class II Ongoing

Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

Reported: June 7, 2023 Initiated: April 26, 2023 #D-0826-2023

Product Description

Reason for Recall

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

Details

Recalling Firm: Akorn, Inc.
Units Affected: N/A
Distribution: Nationwide in the USA and Puerto Rico
Location: Gurnee, IL

Frequently Asked Questions

What product was recalled? ▼

Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs. Recalled by Akorn, Inc.. Units affected: N/A.

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on June 7, 2023. Severity: Moderate. Recall number: D-0826-2023.