Class II Recall

Nephron Sterile Compounding Center LLC

Product
8.4% Sodium Bicarbonate Injection, USP, 1 mEq/mL, 4.2 g/50 mL (84 mg/mL), 1 x 50 mL Pre-Filled Syringe, packaged in a) 10 x 1 syringe carton, b) 30 x 1 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-214-50
Reason
Lack of Assurance of Sterility
Classification
Class II
Status
Terminated
Lot
Lots: SB2001A, Exp. 1/2/2023; SB2005B, SB2005C, Exp. 3/8/2023; SB2006A, SB2006B, SB2006C, Exp. 3/16/2023
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.