PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: August 9, 2017 Initiated: June 15, 2017 #D-1049-2017

Product Description

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

Reason for Recall

Lack of Sterility Assurance

Details

Recalling Firm
Hospira a Pfizer Company
Units Affected
21,436,700 5mL single dose vials
Distribution
U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore
Location
Rocky Mount, NC

Frequently Asked Questions

What product was recalled?
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. Recalled by Hospira a Pfizer Company. Units affected: 21,436,700 5mL single dose vials.
Why was this product recalled?
Lack of Sterility Assurance
Which agency issued this recall?
This recall was issued by the FDA Drug on August 9, 2017. Severity: Moderate. Recall number: D-1049-2017.