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FDARecalled Jun 7, 2023 · #D-0847-2023

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 Fores...

Hazard

Class II — temporary health risk

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Description

CGMP Deviations: Firm went out of business and could no longer continue stability studies. Classification: Class II Distribution: Nationwide in the USA and Puerto Rico

Product details

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
Type
Drugs
Manufacturer
Akorn, Inc.
Model numbers
UPCs