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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 June 15, 2017 and is designated Class II. Reason for recall: Lack of Sterility Assurance The recall status is terminated (terminated July 20, 2020). Affected quantity: 21,436,700 5mL single dose vials.

Recall Details

Product Type: Drugs
Report Date: August 9, 2017
Initiation Date: June 15, 2017
Termination Date: July 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