Sodium Bicarbonate Injection (Hospira) – sterility concern (2017)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Hospira a Pfizer Company
Lot Codes / Batch Numbers
Lot: 72109EV Exp. 12/01/2018, Lot: 72110EV Exp. 12/01/2018, Lot: 72112EV Exp. 12/01/2018, Lot: 72113EV Exp. 12/01/2018, Lot: 72114EV Exp. 12/01/2018, Lot: 73068EV Exp. 01/01/2019, Lot: 73071EV Exp. 01/01/2019, Lot: 73072EV Exp. 01/01/2019, Lot: 73224EV Exp. 01/01/2019, Lot: 73225EV Exp. 01/01/2019, Lot: 73230EV Exp. 01/01/2019, Lot: 73231EV Exp. 01/01/2019, Lot: 73232EV Exp. 01/01/2019, Lot: 73233EV Exp. 01/01/2019, Lot: 73234EV Exp. 01/01/2019, Lot: 73235EV Exp. 01/01/2019, Lot: 73236EV Exp. 01/01/2019, Lot: 73298EV Exp. 01/01/2019, Lot: 74058EV Exp. 02/01/2019, Lot: 74104EV Exp. 02/01/2019, Lot: 74105EV Exp. 02/01/2019, Lot: 74106EV Exp. 02/01/2019, Lot, 74107EV Exp. 02/01/2019, Lot: 74197EV Exp. 02/01/2019, Lot: 74198EV Exp. 02/01/2019, Lot: 74199EV Exp. 02/01/2019, Lot: 74200EV Exp. 02/01/2019, Lot: 74201EV Exp. 02/01/2019, Lot: 75171EV Exp. 03/01/2019, Lot: 75172EV Exp. 03/01/2019, Lot: 75173EV Exp. 03/01/2019, Lot: 75174EV Exp. 03/01/2019, Lot: 75175EV Exp. 03/01/2019, Lot: 75176EV Exp. 03/01/2019, Lot: 75177EV Exp. 03/01/2019, Lot: 75178EV Exp. 03/01/2019. Lot: 75293 Exp. 03/01/2019, Lot: 75418EV Exp. 03/01/2019, Lot: 75419EV Exp. 03/01/2019
Products Sold
Lot: 72109EV Exp. 12/01/2018, Lot: 72110EV Exp. 12/01/2018, Lot: 72112EV Exp. 12/01/2018, Lot: 72113EV Exp. 12/01/2018, Lot: 72114EV Exp. 12/01/2018, Lot: 73068EV Exp. 01/01/2019, Lot: 73071EV Exp. 01/01/2019, Lot: 73072EV Exp. 01/01/2019, Lot: 73224EV Exp. 01/01/2019, Lot: 73225EV Exp. 01/01/2019, Lot: 73230EV Exp. 01/01/2019, Lot: 73231EV Exp. 01/01/2019, Lot: 73232EV Exp. 01/01/2019, Lot: 73233EV Exp. 01/01/2019, Lot: 73234EV Exp. 01/01/2019, Lot: 73235EV Exp. 01/01/2019, Lot: 73236EV Exp. 01/01/2019, Lot: 73298EV Exp. 01/01/2019, Lot: 74058EV Exp. 02/01/2019, Lot: 74104EV Exp. 02/01/2019, Lot: 74105EV Exp. 02/01/2019, Lot: 74106EV Exp. 02/01/2019, Lot; 74107EV Exp. 02/01/2019, Lot: 74197EV Exp. 02/01/2019, Lot: 74198EV Exp. 02/01/2019, Lot: 74199EV Exp. 02/01/2019, Lot: 74200EV Exp. 02/01/2019, Lot: 74201EV Exp. 02/01/2019, Lot: 75171EV Exp. 03/01/2019, Lot: 75172EV Exp. 03/01/2019, Lot: 75173EV Exp. 03/01/2019, Lot: 75174EV Exp. 03/01/2019, Lot: 75175EV Exp. 03/01/2019, Lot: 75176EV Exp. 03/01/2019, Lot: 75177EV Exp. 03/01/2019, Lot: 75178EV Exp. 03/01/2019. Lot: 75293 Exp. 03/01/2019, Lot: 75418EV Exp. 03/01/2019, Lot: 75419EV Exp. 03/01/2019
Hospira a Pfizer Company is recalling 8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL), Rx Only due to Lack of Sterility Assurance. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of Sterility Assurance
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
PR
Page updated: Jan 7, 2026