Exela Pharma Sciences, LLC, (Exela) has issued a voluntary nationwide recall of Sodium Bicarbonate Injection, USP 8.4%, 50 mEq/50 mL vial, 20 count cartons due to a small number of reports of vial breakage during shipping and handling.
Risk Statement
Vial breakage and flying glass poppers pose serious risks, which may result in injury to healthcare providers or patients. Exela has received up to five (5) reports of flying glass injury to the skin, eye, and other parts of the body. However, they have not received any reports of sterility failures.
The Sodium Bicarbonate Injection is used to treat metabolic acidosis, which can happen with kidney failure, and as an emergency treatment for certain types of severe low blood pressure.
The products are packed in a 50 mL glass vial, 20 vials per carton.
The breakage has only been reported with the 50 mL vials of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL lots affecting up to 49 lot numbers. They are labelled with Exela brand (Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1, Figure 1) as well as Civica brand (Carton NDC: 72572-740-20; Vial NDC: 72572-740-1, Figure 2).
You can identify the Exela products; Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1, by their 50ml vial containing a yellow flip-top safety cap.
Their cartons have purple strips and contain information about the product concentration and manufacturer name, “Exela Pharma Sciences” in the right-hand corner. The vial label is in a purple stripe with concentration information and the manufacturer name, “Exela Pharma Sciences”, on the back.
You can identify the Civica products; Carton NDC: 72572-740-20; Vial NDC: 72572-740-1, by their 50ml vial containing a yellow flip-top safety cap. Their cartons contain a green stripe with the product concentration information and manufacturer name, “Civica”, in the lower left-hand corner. The vial label bears a green stripe with concentration information and the manufacturer’s name on the back.
The affected lots were distributed in up to 20 cartons and the recall is not expected to cause a drug shortage.
This recall affects all lots of the recalled products that were distributed nationwide to wholesalers, distributors and hospitals from December 16, 2021, to August 10, 2022.
Actions Taken by Exela
Exela is notifying its distributors and customers of the recall via certified mail and is arranging for the return of all recalled vials. Patients with the product should discontinue the use, segregate, submit a return request to Exela, and wait for shipping instructions from Exela.
Customers with questions regarding this recall contact Exela by phone (828-341-6118 x1017) or email ([email protected]) Monday through Friday, 9:00 am – 5:00 pm ET. Customers are also advised to contact their healthcare providers in case of any adverse reaction or other concerns.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail, fax by calling 1-800-FDA-1088.
