The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1049-2017·Announced 2017-08-09

Hospira Recalls Sodium Bicarbonate Additive Solution Due to Sterility Concerns

Hospira is recalling specific lots of Sodium Bicarbonate 4% Additive Solution because they may lack sterility assurance. The recall covers 21.4 million vials distributed in the U.S. and internationally.

The agency’s classification

FDA (Drugs): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 solution, which poses a risk of serious infection or adverse health consequences, meeting the criteria for a Severe rating.

Plain-English summary

Hospira, a Pfizer company, is recalling specific lots of Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL. The recall is due to a lack of sterility assurance, which means the product may not be sterile as required for its intended use. The affected product is available as single-dose vials and 25-vial cartons and is prescribed only.

The recall involves 21,436,700 5 mL single-dose vials. The affected lots include 72226EV, 72236EV, 75382EV, 75383EV, and 7538EV, with expiration dates ranging from December 2018 to March 2019. The product was distributed in the United States (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore.

Healthcare providers and patients should stop using the affected lots and contact Hospira for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
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
Manufacturer
Hospira a Pfizer Company
Category
Drug — Injectable Solution
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 (1)

  • Exp 03/01/2019

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.

See all 4 products in this recall →

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