Exela Pharma Sciences LLC 2023-11-29 Health critical FDA
Health · FDA · Recall #FDA-D-0116-2024
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose… Recall
Issued November 29, 2023 · Exela Pharma Sciences LLC
In November 2023, Exela Pharma Sciences LLC recalled the 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose…, 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
Presence of Particulate Matter: Silicone
What you should do
- 1 Stop using 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 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
- November 29, 2023
- Units affected
- Not reported
- Sold at
- Nationwide
- Recall number
- FDA-D-0116-2024
- 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 903rd Health recall we've logged in 2023.