Hospira Recalls 8.4% Sodium Bicarbonate Injection Due to Sterility Concerns
Hospira is recalling 8.4% Sodium Bicarbonate Injection vials because they may lack sterility assurance. The recall covers 91,483,150 vials distributed in the U.S. and internationally.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a lack of sterility assurance in an injectable medication, which poses a risk of serious infection or injury, meeting the criteria for a Severe rating.
Plain-English summary
Hospira, a Pfizer Company, is recalling 8.4% Sodium Bicarbonate Injection, USP 50 mL single-dose vials (NDC: 0409-6625-02) due to a lack of sterility assurance. The affected product is a prescription-only medication manufactured in Lake Forest, Illinois.
The recall includes 91,483,150 vials across multiple lots with expiration dates ranging from December 2018 to March 2019. These products were distributed in the United States (including Puerto Rico), the Dutch Antilles, Barbados, Canada, the Philippines, Kuwait, and Singapore.
Healthcare providers and patients should stop using the affected vials and contact Hospira for further instructions. The FDA has classified this recall as Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- 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
- Manufacturer
- Hospira a Pfizer Company
- Category
- Drug — Injectable Medication
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 4 recalled by Hospira a Pfizer Company under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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