Fresenius Kabi Compounding, LLC 2024-10-30 Health serious FDA
Health · FDA · Recall #FDA-D-0016-2025
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag,… Recall
Issued October 30, 2024 · Fresenius Kabi Compounding, LLC
In October 2024, Fresenius Kabi Compounding, LLC recalled the Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag,…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
cGMP violations
What you should do
- 1 Stop using Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Fresenius Kabi Compounding, 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
- Fresenius Kabi Compounding, LLC
- Category
- Health
- Recall date
- October 30, 2024
- Units affected
- Not reported
- Sold at
- Product was distributed to 125 direct accounts nationwide.
- Recall number
- FDA-D-0016-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Fresenius Kabi Compounding, LLC has 8 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.