Vial Breakage Reports Lead to Class I Recall

Exela Pharma Sciences is recalling 49 lots of sodium bicarbonate injection 8.4% labeled under the Exela and Civica brands after receiving reports of vial breakage and flying glass when the product was pressurized to prepare for administration. The recall, included in the November 2, 2022, US Food and Drug Administration (FDA) Enforcement Report, was designated Class I by the FDA. The classification warns use of the product could cause serious adverse health consequences or death.

“Exela has received 5 reports of flying glass injuring skin, eye, and/or other parts,” the company announced in an October 12, 2022, statement. “There have been no reports of sterility failures.”

The recall affects the following products, which were distributed throughout the United States to wholesalers, distributors, and other customers between December 16, 2021, and August 10, 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 lots P0001497 (Exp. 12/23), P0001600 (Exp. 2/24), and P0001663 (Exp. 3/24); 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 P0001370, P0001371, and P0001372 (Exp. 10/23), P0001433 and P0001434 (Exp. 11/23), P0001443, P0001468, P0001469, P0001470, P0001495, P0001505, P0001506, P0001509, P0001510, P0001511, and P0001512 (Exp. 12/23), P0001560, P0001561, P0001562, P0001564, P0001566, P0001567, and P0001568 (Exp. 1/24), P0001571, P0001572, P0001573, P0001574, P0001578, P0001579, P0001580, P0001583, P0001586, P0001587, P0001588, P0001593, P0001594, P0001610, P0001618, P0001619, and P0001654 (Exp. 2/24), P0001644, P0001645, P0001646, P0001662, and P0001664 (Exp. 3/24), and P0001730 (Exp. 5/24).

Exela Pharma Sciences voluntarily initiated the recall October 4, 2022. The FDA issued its Class I designation on October 27, 2022. Exela said the recall is not expected to cause a shortage of the drug.

“Customers that have product which is being recalled should discontinue use, segregate the recalled product, submit a recall stock response form to Exela (even if there is no product to return), and hold the product until shipment instructions are provided by Exela,” the company directed.

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