The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-1073-2019·Announced 2019-04-10

Pfizer Recalls Sodium Bicarbonate Injection Vials Due to Glass Particulates

Pfizer is recalling 8.4% Sodium Bicarbonate Injection vials because they contain glass particulates. The recall covers 283,400 vials distributed in the United States and Puerto Rico.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source metadata explicitly identifies the agency classification as Class I. According to the severity rubric, an FDA Class I recall corresponds to a score of 5 (Critical).

Plain-English summary

Pfizer Inc. is recalling 8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL) 50 mL Single-dose fliptop vials. The recall is due to the presence of particulate matter, specifically glass particulates, in the product. The affected product is identified by NDC 0409-6625-02 and was manufactured by Hospira, Inc. in Lake Forest, IL.

The recall involves 283,400 vials. The specific lots affected are 79-238-EV (Exp. 1 July 2019), 79-240-EV (Exp. 1 July 2019), and 80-088-EV (Exp. 1 August 2019). These products were distributed in the United States and Puerto Rico.

Healthcare providers and patients should stop using the affected vials and contact Pfizer or their supplier for instructions on how to return the product. This recall is classified as Class I by the FDA, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.

The recalled product

Product
8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL) 50 mL Single-dose fliptop vial, 25 vials per carton, Rx only Hospira, Inc. Lake Forest, IL 60045 USA ---- NDC 0409-6625-02
Manufacturer
Pfizer Inc.
Category
Drug — Injectable
Hazard
Affected units
283,400

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 (3)

  • Lots: 79-238-EV Exp. 1 July 2019
  • 79-240-EV Exp. 1 July 2019
  • 80-088-EV Exp. 1 August 2019

Distribution

Distributed in 1 state:

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