PlainRecalls
FDA Drug Moderate Class II Terminated

8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA, NDC: 0409-6625-02

Reported: August 9, 2017 Initiated: June 15, 2017 #D-1047-2017

Product Description

8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA, NDC: 0409-6625-02

Reason for Recall

Lack of Sterility Assurance

Details

Recalling Firm
Hospira a Pfizer Company
Units Affected
91,483,150 50 mL 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?
8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA, NDC: 0409-6625-02. Recalled by Hospira a Pfizer Company. Units affected: 91,483,150 50 mL 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-1047-2017.