FDA-Drug2019-05-01Class III
Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-25
Akorn Inc
Hazard
Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability testing.
Sold states
U.S.A. Nationwide
Affected count
5,380 cartons (25 ampules per carton)
Manufactured in
1925 W Field Ct Ste 300, N/A, Lake Forest, IL, United States
Products
Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-25
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1241-2019Don't want to check this manually?
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