D-0828-2023 Class II Ongoing

Recalled by Akorn, Inc. — Gurnee, IL

Recall Details

Product Type
Drugs
Report Date
June 7, 2023
Initiation Date
April 26, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

Midazolam Injection, USP 2mg/2mL (1 mg/mL) For Intramuscular or Intravenous Use Only, 2mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Reason for Recall

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

Distribution Pattern

Nationwide in the USA and Puerto Rico

Code Information

All Lots