FENTANYL CITRATE
Generic: FENTANYL CITRATE
Fresenius Kabi USAManufacturer
INTRAMUSCULAR, INTRAVENOUSRoute
FENTANYL CITRATEActive Substance
2019-05-03Original Approval
FENTANYL CITRATE is FDA application ANDA210762, sponsored by FRESENIUS KABI USA. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.
Recalls
Class III2015-05-13
Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV or IM Use Preservative Free, 25 Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
Class III2015-02-16
Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5 mL Single Dose Vials, For Intravenous or IFailed Impurities/Degradation Specifications; 12 month stability testing.
Class II2020-07-20
Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials, Rx only, Distributed by HosLack of Assurance of Sterility; potential loose metal overseal crimp defects.
Class II2014-06-27
Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, Rx only. HLack of Assurance of Sterility: Fliptop vial crimps are loose or missing.
Class II2014-12-03
Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial (C-II), Rx only, 25 units perLack of Assurance of Sterility; improperly crimped fliptop vials
Top Reported Reactions
1
DEPENDENCE
3,935 reports
2
OVERDOSE
2,452 reports
3
DEATH
2,062 reports
4
DRUG ABUSE
1,734 reports
5
TOXICITY TO VARIOUS AGENTS
1,383 reports
6
ILL-DEFINED DISORDER
1,288 reports
7
CARDIAC ARREST
916 reports
8
RESPIRATORY ARREST
736 reports
9
DRUG INEFFECTIVE
712 reports
10
DRUG HYPERSENSITIVITY
628 reports