FDA recall D-1279-2022

Nephron Sterile Compounding Center LLC · Class II · drug

Product

8.4% Sodium Bicarbonate Injection, USP, 4.2 g/50 mL (84 mg/mL) 1 mEq/mL syringe, packaged in 1 x 50 mL Pre-Filled Syringe per carton, 30 x 1 syringe carton per case, Rx Only Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-214-50

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2022-06-30
Report date: 2022-07-27
Termination date: 2024-06-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: West Columbia, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1279-2022