Exela Pharma Sciences LLC 2022-12-21 Health critical FDA
Health · FDA · Recall #FDA-D-0080-2023
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials,… Recall
Issued December 21, 2022 · Exela Pharma Sciences LLC
In December 2022, Exela Pharma Sciences LLC recalled the 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials,…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
What you should do
- 1 Stop using 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Exela Pharma Sciences LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Exela Pharma Sciences LLC
- Category
- Health
- Recall date
- December 21, 2022
- Units affected
- Not reported
- Sold at
- Nationwide within the United States
- Recall number
- FDA-D-0080-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Exela Pharma Sciences LLC has 5 recalls in our database, including 3 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.