Potential for Glass Particulate in Injections Prompts Recall

A Class I recall has been issued for 24,900 vials of 4.2% sodium bicarbonate injection distributed by Hospira, a Pfizer company, because of the potential presence of glass particulate, according to the November 15, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The designation is the FDA’s most serious and communicates the possible risk of serious adverse health consequences or death with use of the product.

The recall affects 4.2% sodium bicarbonate injection, 5 mEq/10 mL (0.5 mEq/mL), in a glass ABBOJECT syringe, packaged as 1 vial and injector per carton (NDC 0409-5534-24), from lot GJ5007 (Exp. 8/1/24). The vials were distributed throughout the US and Puerto Rico, but not to government accounts or foreign consignees.

Pfizer Inc. voluntarily initiated the recall October 2, 2023. On November 9, 2023, the FDA designated the recall Class I.

“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,” Hospira stated in an October 2, 2023, announcement. “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.”

Sodium bicarbonate injection is indicated in the treatment of metabolic acidosis, certain drug intoxications, poisoning by salicylates or methyl alcohol, and in hemolytic reactions. It is also indicated in the treatment of severe diarrhea.