FDA recall D-0413-2024

SCA Pharmaceuticals, LLC · Class II · drug

Product

neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL fill 6 mL Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0750-09, Bar Code 70004075009

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2023-11-09
Report date: 2024-04-03
Termination date: 2024-08-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Windsor, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0413-2024