Hospira, Inc. Recalls Sodium Bicarbonate Injection and Atropine Sulfate Injection


Medical Recalls

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Recalled Hospira Sodium Bicarbonate and Atropine


Hospira, Inc., a Pfizer company, is voluntarily recalling the lots listed in the table below of 4.2% Sodium Bicarbonate Injection, USP ABBOJECT® Glass Syringe, 5 mEq/10 mL; 8.4% Sodium Bicarbonate Injection, USP Lifeshield® ABBOJECT® Glass Syringe, 50 mEq/50 mL; and Atropine Sulfate Injection, USP Lifeshield® ABBOJECT® Glass Syringe, 1 mg/10 mL to the user level. The recall was initiated due to the potential for presence of glass particulate matter, identified during product inspection.

Should a patient receive an injectable product containing glass particulate matter as a result of this issue, the patient may experience serious adverse events. Potential complications related to injection of visible and subvisible inert particles include inflammation of a vein, granuloma, and blockage of blood vessels or life-threatening blood clot events. The frequency and severity of these adverse events could vary depending upon a variety of factors including the size and number of particles in the drug product, patient comorbidities (such as age, compromised organ function), and presence or absence of vascular anomalies.

The risk is reduced by the possibility of detection, as the label contains a clear statement directing the healthcare professional to visually inspect the product for particulate matter and discoloration prior to administration.

To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for these lots.

Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO3) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. It is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products. It is also indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate.

Atropine Sulfate Injection, USP is a sterile, nonpyrogenic isotonic solution of atropine sulfate monohydrate in water for injection with sodium chloride sufficient to render the solution isotonic. It is administered parenterally by intravenous injection and is indicated for temporary blockade of severe or life-threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest.

The NDC, Lot Number, Expiration Date, and Configuration details for the impacted products are indicated in the table below. The products were distributed nationwide to wholesalers/hospitals/institutions in the United States and Puerto Rico from March 14, 2023 through June 29, 2023.

"Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified direct consignees by letter to arrange for the return of any recalled product."

Wholesalers, hospitals, institutions, and doctors with an existing inventory of a lot which is being recalled should discontinue use, stop distribution and quarantine the product immediately. 

This recall is being executed with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

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Consumer Contact: -

For additional assistance, call Sedgwick Inc. at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.

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Contact Center

Contact Information

Area of Support

Pfizer Medical Information 1-800-438-1985, option 3
(9am to 5pm ET Monday
through Friday)
www.pfizermedinfo.comExternal Link Disclaimer
For medical questions
regarding the product
Pfizer Safety 1-800-438-1985, option 1
(24 hours a day;
7 days a week)
To report adverse events
and product complaints

Product

NDC

Lot Number

Expiration Date

Presentation

Configuration/Count

4.2% Sodium
Biocarbonate
Injection,
USP
ABBOJECT®
Glass
Syringe
Carton:
0409-5534-24
Case:
0409-5534-14
GX1542 1JAN2025 5 mEq/10 mL
(0.5 mEq/mL)
1-10 mL
Abboject
Syringe per
carton
10 cartons per
bundle
Case Pack
5 X 10-10 mL
8.4% Sodium
Biocarbonate
Injection,
USP
Lifeshield®
ABBOJECT®
Glass
Syringe
Carton:
0409-6637-24
Case:
0409-6637-14
HA7295 1MAR2025 50 mEq/50 mL
(1 mEq/mL)
1-50 mL
Abboject
Syringe per
carton
10 cartons per
bundle
Case Pack
5 X 10-50 mL
Atropine
Sulfate
Injection,
USP
Lifeshield®
ABBOJECT®
Glass
Syringe
Carton:
0409-4911-11
Case:
0409-4911-34
GY2496 1FEB2025 1 mg/10 mL
(0.1 mg/mL)
1-10 mL
Abboject
Syringe per
carton
10 cartons per
bundle
Case Pack
5 X 10-10 mL

Report a Problem With This Product

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

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You Are Leaving Us

This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.

Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.

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