FDA Drug Class II — Moderate

Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose vial (NDC 0409-6609-02), b.) 25 vial carton (NDC 0409-6609-25), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA

Hazard

Lack of Sterility Assurance

Products

Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose vial (NDC 0409-6609-02), b.) 25 vial carton (NDC 0409-6609-25), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA
Brand
Hospira a Pfizer Company
UPC
a.) one vial: Lot: 72226EV Exp. 12/01/2018 Lot: 72236EV Exp. 12/01/2018 Lot: 75382EV Exp. 03/01/2019 Lot: 75383EV Exp. 03/01/2019 b.) 25 vial carton: Lot: 7538EV; Exp 03/01/2019

Units Affected

21,436,700 5mL single dose vials