Neostigmine Methylsulfate 5mL Recalled

July 2, 2018

Fagron Sterile Services is voluntarily recalling two lots of Neostigmine Methylsulfate 5mL syringes due to mislabeling.

On June 29, 2018, Fagron Sterile Services announced it is voluntarily recalling two lots of Neostigmine Methylsulfate 5mL syringes to the user/hospital/clinic level due to mislabeling. The affected lots are being recalled because a customer complained that some of the syringe units were incorrectly labeled as Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL. The company states that secondary packaging is properly labelled.

Neostigmine Methylsulfate Injection, USP is used to treat the effects of non-depolarizing neuromuscular blocking agents post-surgery. Administering the incorrect amount of product may lead to nausea, vomiting, diarrhea, excessive salivation and sweating, increased bronchial secretions, miosis, bradycardia or tachycardia, cardiospasm, bronchospasm, incoordination, muscle cramps, fasciculation, paralysis, or possibly Cholinergic Crisis. No adverse events have been reported as of June 29, according to the company.

The recalled product is supplied by Fagron Sterile Services in a single-use syringe and is produced by Fagron Sterile Services into 5mL or 3mL fill presentations of 1 mg/mL of Neostigmine Methylsulfate. Impacted lots were distributed nationwide to hospitals and surgical clinics.

Adverse reactions may be reported to FDA through its MedWatch program.

Source: FDA