FDAClass IIAugust 9, 2017

8.4% Sodium Bicarbonate Inj recall: Sterility Concern

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…

Why was 8.4% Sodium Bicarbonate Inj recalled?

Lack of Sterility Assurance

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Hospira a Pfizer Company
Quantity
91,483,150 50 mL single dose vials
Distribution
U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore
Recall date
August 9, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls