Akorn, Inc. recalls Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx only, 2 mL Ampule, Warni
Recalled January 19, 2022 · FDA recall D-0460-2022 · Akorn
Hazard
Subpotent Drug: Out of specification for assay at the 30-month stability timepoint. · FDA Class II
Units
31,510 ampules
Sold at
Nationwide in the USA
Description
Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Product
Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx only, 2 mL Ampule, Warning - May be habit forming, Preservative Free, Manufactured by Akorn, Inc. Lake Forest, IL 60045, NDC 17478-0050-02.
Manufacturer(s)
Akorn, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →