Medication Monitor

Generic Name (Trade Name—Company)
July 9, 2018

Neostigmine methylsulfate 5-mL syringes

(No trade names—Fagron Sterile Services)
Two lots of recalled syringe units may be incorrectly labeled

Fagron Sterile Services is voluntarily recalling two lots of neostigmine methylsulfate 5-mL syringes because some syringe units containing 1 mg/mL, 5 mg per 5mL, are incorrectly labelled as 1 mg/mL, 3 mg per 3mL. Secondary packages are properly labelled as neostigmine methylsulfate 1 mg/mL, 5 mg per 5mL.

If 5 mL rather than the intended 3mL is administered to a patient, adverse events overdosage can range from nausea, vomiting, diarrhea, excessive salivation and sweating, increased bronchial secretions, miosis, bradycardia or tachycardia, cardiospasm, bronchospasm, incoordination, muscle cramps, fasciculation, and paralysis, to cholinergic crisis resulting in death.

To date, Fagron has not received any reports of adverse events or injuries related to this recall.

Neostigmine methylsulfate injection is a cholinesterase inhibitor indicated for reversal of the effects of nondepolarizing neuromuscular blocking agents after surgery.