On October 13, 2022, the U.S. Food and Drug Administration (FDA) reported Exela Pharma Sciences, LLC’s (Exela’s), voluntary recall of 49 lots of sodium bicarbonate injection, USP, 8.4%, 50 mEq/50 ml vial, 20-count carton, to the consumer level because of potential vial breakage and flying glass when pressurized while preparing for administration.
Exela said it has received five reports of flying glass injuring the skin, eye, or other parts of the body. To date, Exela has not reported any sterility failures.
The vials are labeled with 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).
The following products are included in the recall. All are supplied in 20-count cartons only.
|
Brand |
Lot |
Expiration Date |
|
Exela |
P0001370 |
10/2023 |
|
Exela |
P0001371 |
10/2023 |
|
Exela |
P0001372 |
10/2023 |
|
Exela |
P0001433 |
11/2023 |
|
Exela |
P0001434 |
11/2023 |
|
Exela |
P0001443 |
12/2023 |
|
Exela |
P0001468 |
12/2023 |
|
Exela |
P0001469 |
12/2023 |
|
Exela |
P0001470 |
12/2023 |
|
Exela |
P0001495 |
12/2023 |
|
Exela |
P0001505 |
12/2023 |
|
Exela |
P0001506 |
12/2023 |
|
Exela |
P0001509 |
12/2023 |
|
Exela |
P0001510 |
12/2023 |
|
Exela |
P0001511 |
12/2023 |
|
Exela |
P0001512 |
12/2023 |
|
Exela |
P0001560 |
01/2024 |
|
Exela |
P0001561 |
01/2024 |
|
Exela |
P0001562 |
01/2024 |
|
Exela |
P0001564 |
01/2024 |
|
Exela |
P0001566 |
01/2024 |
|
Exela |
P0001567 |
01/2024 |
|
Exela |
P0001568 |
01/2024 |
|
Exela |
P0001571 |
02/2024 |
|
Exela |
P0001572 |
02/2024 |
|
Exela |
P0001573 |
02/2024 |
|
Exela |
P0001574 |
02/2024 |
|
Exela |
P0001578 |
02/2024 |
|
Exela |
P0001579 |
02/2024 |
|
Exela |
P0001580 |
02/2024 |
|
Exela |
P0001583 |
02/2024 |
|
Exela |
P0001586 |
02/2024 |
|
Exela |
P0001587 |
02/2024 |
|
Exela |
P0001588 |
02/2024 |
|
Exela |
P0001593 |
02/2024 |
|
Exela |
P0001594 |
02/2024 |
|
Exela |
P0001610 |
02/2024 |
|
Exela |
P0001618 |
02/2024 |
|
Exela |
P0001619 |
02/2024 |
|
Exela |
P0001644 |
03/2024 |
|
Exela |
P0001645 |
03/2024 |
|
Exela |
P0001646 |
03/2024 |
|
Exela |
P0001654 |
02/2024 |
|
Exela |
P0001662 |
03/2024 |
|
Exela |
P0001664 |
03/2024 |
|
Exela |
P0001730 |
05/2024 |
|
Civica |
P0001497 |
12/2023 |
|
Civica |
P0001600 |
02/2024 |
|
Civica |
P0001663 |
03/2024 |
Both brands can be identified by the NDC numbers and the yellow flip-top safety cap on the 50 ml vial. The Exela carton is printed with a purple stripe containing the concentration information and the manufacturer name “Exela Pharma Sciences” in the lower right-hand corner; the vial label is also printed with a purple stripe containing the concentration information and “Exela Pharma Sciences” is printed on the back. The Civica product has the same information printed on a green stripe and uses the manufacturer name “Civica.”
All affected products were distributed nationwide to wholesalers, distributors, and customers from December 16, 2021–August 10, 2022.
Exela notified customers by email and certified mail and is arranging for return and replacement of all recalled product. Exela recommended that customers with recalled products discontinue its use, segregate it, submit a recall stock response form, and hold the product until shipment instructions are provided.
Customers with questions can contact Exela at 828-341-6118, ext. 1017, or recall@exela.us Monday–Friday, from 9 am–5 pm EST. Consumers should contact their healthcare provider if they experience any problems after using the product.
Healthcare professionals and consumers should report any adverse reactions or quality problems they experienced using the product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.