FDA-Drug2022-01-19Class II
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.
Akorn, Inc.
Hazard
Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Sold states
Nationwide in the USA
Affected count
31,510 ampules
Manufactured in
1925 W Field Ct Ste 300, N/A, Lake Forest, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0460-2022Don't want to check this manually?
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