Exela Pharma Sciences LLC: 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Phar

Hazard

Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.

Details from the source

Reason for recall: Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration. Distribution: Nationwide within the United States Quantity: 489,600 vials Lot/code info: Lots: P0001178 Exp. 05/2023; P0001298, P0001301, P0001313, P0001314, P0001317 Exp. 08/2023; P0001330, P0001464 Exp. 09/2023; P0001442 Exp. 11/2023; P0001467, P0001472, P0001486, P0001532 Exp. 12/2023.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.