December 27, 2016
Fentanyl Citrate 1500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 150 mL Bag, Single-Dose Bag has been recalled due to concerns about sterility, according to the latest Drug Enforcement Report from the US Food and Drug Administration.
Fentanyl is a powerful opioid agonist used to treat severe pain. Like other drugs of this type, it has a high risk of addiction and dependence. Cantrell Drug Company voluntarily initiated the recall of more than 400 bags on November 18, 2016.
The drug is one of several Cantrell has been forced to recall in recent months due to a lack of sterility assurance. Just this week Pharmacy Learning Network has reported that Glycopyrrolate 1 mg/5 mL (0.2 mg/mL) Injection Solution, 5-mL Single-Dose Syringe; and Heparin Sodium, 1 USP Unit/2 mL (0.5 USP Units/mL) in 0.45% Sodium Chloride, Single-Dose Syringe were recalled by the organization for these same reasons.
The US Food and Drug Administration classified the recall as Class II, meaning that exposure to Fentanyl Citrate could cause temporary health problems, but that it poses only a slight threat of serious adverse response.—Sean McGuire
Enforcement Report. US Food and Drug Administration Website. http://www.accessdata.fda.gov/scripts/ires/index.cfm. Published December 21, 2016. Accessed December 27, 2016.