Exela Pharma is recalling an additional 14 lots of sodium bicarbonate injection because of a broken vial.
A broken vial has been found among additional lots of Exela Pharma Sciences’ sodium bicarbonate injection. As a result, the company is recalling 14 more lots. (Labels shown below.) This is in addition to the 49 lots recalled in October 2022, also because of broken vials. The additional lots were distributed October 26, 2021, through April 25, 2022.
Sodium bicarbonate injection is used for treatment of metabolic acidosis, which is the buildup of acid in the body because of kidney or liver failure.
Related: Vial Breakage Leads to Recall of 49 Lots of Sodium Bicarbonate
During the latest inspection of Exela’s retained product from the 14 lots, one vial showed breakage, which presents the potential for flying glass injuring skin and eyes. There have been no reports of breakage or injury from the additional lots, but previously Exela received five reports of flying glass and injury among the lots involved in the first recall.
The total 63 recalled lots include more than 2.7 million vials. There have been no reports of sterility failures to date with any of the 63 lots.
The product is packaged in a 50 mL glass vial, 20 vials per carton. The recall includes both the Exela brand (Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1) and Civica brand (Carton NDC: 72572-740-20; Vial NDC: 72572-740-1). Lot numbers and expiration dates can be found here.