Neostigmine Methylsulfate 5mL Recalled

Article

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

 

Recent Videos
Simon Wright from Almac Pharma Services chats about shifting demand for commercial manufacturing services and how service providers are adapting to meet demand.
Ian Lafferty from Upperton discusses the trends and challenges facing sterile manufacturing and how partnering with CDMOs can help innovators progress to the market.
Kate Coleman, vice president regulatory affairs, quality and compliance, Arriello, chats about industry trends and technological advances.
Industry Outlook 2025: The Rising Prominence of AI in Pharma
Adam Sherlock, CEO of Qinecsa, discusses the changing political landscapes in the US and Europe and how that may affect the bio/pharma industry.
Related Content
© 2025 MJH Life Sciences

All rights reserved.