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Analgesic Agent Recalled


December 07, 2016

Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL has been voluntarily recalled by its manufacturer after numerous health care professionals and patients complained of broken tips on the ampules.

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Fentanyl Citrate is a potent narcotic analgesic administered intravenously or intramuscularly to help relieve pain. Hospira Inc, the drug producer, initiated the recall on November 1, 2016, according a Drug Enforcement Report released by the US Food and Drug Administration.  

The recall is being attributed to a “Lack of Assurance of Sterility” after it was discovered that ampules protecting the solution were damaged, which could have caused the drug to become contaminated and endanger patients.

As such, the FDA has designated it a class II recall, indicating that exposure to Fentanyl Citrate Injection could result in temporary or medically reversible adverse health consequences, with little probability of serious adverse health consequences.—Sean McGuire 

Sources

http://www.accessdata.fda.gov/scripts/ires/index.cfm#Product_150928

https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=4059

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