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D-1049-2017 Class II Terminated

Recalled by Hospira A Pfizer Company — Rocky Mount, NC

FDA drug recall D-1049-2017 was initiated by Hospira A Pfizer Company on Jun 15, 2017 and is designated Class II. Reason for recall: Lack of Sterility Assurance The recall status is terminated (terminated Jul 20, 2020). Affected quantity: 21,436,700 5mL single dose vials.

Recall details

Product Type: Drugs
Report Date: Aug 9, 2017
Initiation Date: Jun 15, 2017
Termination Date: Jul 20, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 21,436,700 5mL single dose vials

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

Distribution pattern

U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore

Code information

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

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1049-2017
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.