Glass Particulate Prompts Class I Recall for Injection

A Class I recall has been issued for 283,400 vials of 8.4% sodium bicarbonate injection from Hospira, a Pfizer company. According to the April 10, 2019, US Food and Drug Administration (FDA) Enforcement Report, the recall was initiated due to the presence of particular matter identified as glass. 

“The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening if a critical organ is affected,” Pfizer said in a company announcement issued March 15, 2019. “To date, Hospira Inc. has not received reports of any adverse events associated with this issue for these lots.” 

The recall affects 8.4% sodium bicarbonate injection, 50 mEq/50 mL, packaged in 50-mL glass flip-top vials, 25 vials per carton (NDC 0409-6625-02), from lots 79-238-EV (Exp. 7/1/19), 79-240-EV (Exp. 7/1/19), and 80-088-EV (Exp. 8/1/19). The vials were distributed in the United States and Puerto Rico. 

Pfizer voluntarily initiated the recall March 15, 2019. The FDA designated it Class I on March 29, 2019. The designation communicates use of the recalled vials could cause serious adverse health consequences or death. 

Sodium bicarbonate solution is given intravenously for the treatment of metabolic acidosis, which can occur with severe renal disease, uncontrolled diabetes, dehydration, severe diarrhea, circulatory insufficiency due to shock, cardiac arrest, and severe lactic acidosis. Sodium bicarbonate is also indicated for the treatment of some drug intoxications. 

—Jolynn Tumolo