Class I Sodium Bicarbonate Recall Expands

Exela Pharma Sciences is expanding its Class I recall of sodium bicarbonate injection 8.4% to include another 14 lots, according to the December 21, 2022, US Food and Drug Administration (FDA) Enforcement Report. The lots were not initially included in the recall, which was prompted by reports of vial breakage and flying glass when the product was pressurized to prepare for administration, because the company did not consider them affected. However, a recent inspection of retained product from the 14 lots revealed a broken vial.

“There is a potential of flying glass injuring skin, eye, and/or other parts, which could result in either temporary or permanent injury. Within the 63 total recalled lots (which includes more than 2.7 million vials), Exela has received five reports of flying glass injuring skin, eye, and/or other parts,” Exela stated in a November 28, 2022, company announcement. “There have been no complaints of vial breakage or injuries related to the additional 14 lots. There have been no reports of sterility failures to date with any of the 63 lots.”

The recall expansion affects the following products, which were distributed throughout the United States between October 26, 2021, and April 25, 2022:

• Civica sodium bicarbonate injection 8.4%, 50 mEq/50 mL vials (NDC 72572-740-1), 20-vial cartons (NDC 72572-740-20), manufactured for Civica Inc., Lehi, UT, manufactured by Exela Pharma Sciences, Lenoir, NC, from lot P0001490 (Exp. 12/23); and
• Exela sodium bicarbonate injection 8.4%, 50 mEq/50 mL vials (NDC 51754-5001-1), 20-vial cartons (NDC 51754-5001-5), manufactured and distributed by Exela Pharma Sciences, Lenoir, NC, from lots P0001178 (Exp. 5/23); P0001298, P0001301, P0001313, P0001314, and P0001317 (Exp. 8/23); P0001330 and P0001464 (Exp. 9/23); P0001442 (Exp. 11/23); and P0001467, P0001472, P0001486, and P0001532 (Exp. 12/23).

Exela Pharma Sciences voluntarily initiated its recall of the additional lots on November 28, 2022. The FDA issued its Class I designation on December 13, 2022. The classification warns use of the product could cause serious adverse health consequences or death.

Sodium bicarbonate injection is a prescription medicine used for the treatment of metabolic acidosis.