FDA-Drug2017-08-09Class II

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

Hospira a Pfizer Company
Hazard

Lack of Sterility Assurance

Sold states
U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore
Affected count
21,436,700 5mL single dose vials
Manufactured in
4285 N Wesleyan Blvd, N/A, Rocky Mount, NC, United States
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1049-2017

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