Exela Pharma Sciences LLC 2025-04-02 Health serious FDA
Health · FDA · Recall #FDA-D-0303-2025
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose… Recall
Issued April 2, 2025 · Exela Pharma Sciences LLC
In April 2025, Exela Pharma Sciences LLC recalled the 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Lack of Assurance of Sterility
What you should do
- 1 Stop using 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose… 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
- April 2, 2025
- Units affected
- Not reported
- Sold at
- Nationwide
- Recall number
- FDA-D-0303-2025
- 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 691st Health recall we've logged in 2025.