FDA recall D-0963-2022

Nephron Sterile Compounding Center LLC · Class II · drug

Product

Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-902-05

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2022-05-18
Report date: 2022-06-08
Termination date: 2024-08-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: West Columbia, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0963-2022