Drug Used for Reversal of Neuromuscular Block Recalled Due to Mislabeling

Fagron Sterile Services announced a nationwide voluntary recall of 2 lots of Neostigmine Methylsulfate syringes due to a complaint that some “1mg/mL, 5mg per 5mL” units were incorrectly labeled as “1mg/mL, 3mg per 3mL.” Secondary packages, however, are correctly labeled as Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL. 

Neostigmine Methylsulfate Injection, a cholinesterase inhibitor, is indicated to reverse the effects of non-depolarizing neuromuscular blockers after surgery. The single-use syringes were supplied as a 1mg/mL strength in 3mL or 5mL fill volumes. 

Adverse events related to an overdose of Neostigmine Methylsulfate may include nausea, vomiting, diarrhea, excessive salivation/sweating, increased bronchial secretions, miosis, bradycardia or tachycardia, cardiospasm, bronchospasm, incoordination, muscle cramps, fasciculation, paralysis, cholinergic crisis, and even death. 

The affected products contain Lot #C274-000004690 for the 5mg per 5mL product (beyond use date 9/21/18) and Lot # C274-000004678 for the 3mg per 3mL item (beyond use date 9/20/18). The recalled lots were distributed to hospitals and surgical clinics. At this time, the Company has not received any adverse event reports related to this recall.

For more information call (877) 405-8066 or visit jcblabs.com.