Akorn, Inc. recalls Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL, packaged in a)1 mL ampules, b) 2mL ampules, c) 5mL ampules, For I
Recalled June 7, 2023 · FDA recall D-0847-2023 · Akorn
Hazard
CGMP Deviations: Firm went out of business and could no longer continue stability studies. · FDA Class II
Units
N/A
Sold at
Nationwide in the USA and Puerto Rico
Description
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product
Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL, packaged in a)1 mL ampules, b) 2mL ampules, c) 5mL ampules, For Intravenous and Epidural Use, Rx only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
Manufacturer(s)
Akorn, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →