Hospira Issues Recall Due to Particulate Matter

March 18, 2019

The company is recalling 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL) because of glass found in product.

Hospira, Inc., a Pfizer company, announced on March 15, 2019 that it was voluntarily recalling lot numbers 79-238-EV, 79-240-EV and 80-088-EV, NDC# 0409-6625-02, of 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL) to the hospital/institution level because of glass particulates found in the product. While the company has not received any reports of adverse events associated with the recall, administration of a drug containing glass particulates may result in local irritation, swelling, or, more seriously, blockage and clotting in blood vessels.

Used for the treatment of metabolic acidosis and certain drug intoxications, 8.4% Sodium Bicarbonate Injection, USP, is a sterile, hypertonic solution of sodium bicarbonate (NaHCO3) in water administered intravenously and packaged in 50-mL glass fliptop vials in a case pack of 4 x 25–50mL. The affected lots were distributed nationwide in the United States and Puerto Rico from August 2017 through September 2017.

Source: FDA