Exela Pharma Sciences, LLC, expands its recall of Sodium Bicarbonate Injection, USP 8.4%, 50 mEq/50 mL Vial, 20-Count Carton with 10 Lots. The ongoing recall which affected forty-nine (49) lots now adds fourteen (14) more lots bringing the total number of recalled lots to sixty-three (63). The 14 more lots of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20-count carton were distributed October 26, 2021 through April 25, 2022.
Risk Statement
This recall is being made on account of vial breakage due to a potential manufacturing defect that allows for increased risk of vial breakage during the shelf life. Breakage could lead to the potential flying glass injury to the skin, eye or mucous membranes which could cause temporary or permanent injury.
Exela has received up to five (5) reports of flying glass injury to the eyes, skin, and other body parts withing the 63 lots. There have not been any complaints vial breakage or related injuries with the additional fourteen (14) lots. Exela has not received any reports of sterilize failures on any of the 63 lots.
The previous recall did not include the 14 lots because they were not impacted. However, the latest inspection of the fourteen (14) lots of Exela’s products revealed one (1) vial breakage. Exela has not received any field reports of injury for all the sixty-three (63) lots since the beginning of the recall. However, Exela is adding the fourteen (14) lots to the ongoing recall out of abundance of caution.
Product Indication
Sodium Bicarbonate Injection, USP 8.4%, 50 mEq/50 mL is used to treat metabolic acidosis, which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration and extracorporeal circulation of blood.
The additional fourteen (14) lots of Sodium Bicarbonate Injection, USP 8.4%, 50 mEq/50 mL Vial, 20-Count Carton affected by this recall has the following lot numbers and expiration dates:
| Brand | Lot | Expire Date |
| Exela | P0001178 | 05/2023 |
| Exela | P0001298 | 08/2023 |
| Exela | P0001301 | 08/2023 |
| Exela | P0001313 | 08/2023 |
| Exela | P0001314 | 08/2023 |
| Exela | P0001317 | 08/2023 |
| Exela | P0001330 | 09/2023 |
| Exela | P0001464 | 09/2023 |
| Exela | P0001472 | 12/2023 |
| Exela | P0001486 | 12/2023 |
| Exela | P0001532 | 12/2023 |
| Civica | P0001490 | 12/2023 |
| Exela | P0001442 | 11/2023 |
| Exela | P0001467 | 12/2023 |
You can identify the Exela product (Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1) by their NDC numbers and the yellow flip top safety cap on the 50ml vial.
The carton has a purple stripe and contains information on the concentration and manufacturer name. The vial label has a purple stripe with concentration information and manufacturer name at the back.
You can identify the Civica Product (Carton NDC: 72572-740-20; Vial NDC: 72572-740-1) by their NDC numbers and the yellow flip top safety cap on the 50ml vial.
The carton has a green stripe and contains information on the concentration, manufacturer name, “Civica”. The vial label has a green stripe with concentration information, manufacturer name at the back.
The products were distributed nationwide to wholesalers, distributors, and customers on October 26, 2021 and August 10, 2022.
Actions to Take
Exela is notifying its customers and distributors by recall email and is arranging for return of all recalled products. Exela Pharma Science, LLC advises any health care provider or patient who has received the lots being recalled to immediately discontinue use of product, quarantine it upon receipt.
Consumers with the recalled product should immediately stop using the product and contact their health care provider.
The recall is ongoing at this time and Exela Pharma Science, LLC has not yet provided any information on when it will be completed. Consumers with questions regarding the recall may contact Exela’s customer service team by phone (828-341-6118) or email ([email protected]) between 8:00 am and 5:00 pm PST, Monday through Friday. Consumers who have experienced any problems related to the use of the recalled products should contact their healthcare provider immediately.
Healthcare professionals and consumers are encouraged to report any adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
