Vial Breakage Leads to Recall of 49 Lots of Sodium Bicarbonate

Exela Pharma Sciences is recalling 49 lots of sodium bicarbonate injection. The product is used for treatment of metabolic acidosis, which is the buildup of acid in the body because of kidney or liver failure. It is packaged in a 50 mL glass vial, 20 vials per carton. Exela has received five reports of flying glass injuring skin, eye and/or other parts. There have been no reports of sterility failures.

The recall includes both Exela and Civica brands. The products of both manufacturers have a yellow flip-top safety cap on the 50 mL vial. The product was distributed between Dec. 16, 2021, and Aug. 10, 2022.

The Exela carton has an NDC number of 51754-5001-5 and a vial NDC of 51754-5001-1. The carton has a purple stripe containing concentration information and the manufacturer name in the lower right-hand corner. The Civica carton has an NDC number of 72572-740-20 and a vial NDC of 72572-740-1. The carton has green stripe containing concentration information and the manufacturer name in the lower right-hand corner.

Lot numbers and expiration dates can be found here.

Exela does not expect this recall to impact drug supply.