FDAFDA · Food and drugs·Recall number D-0017-2025
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-029-58
Published October 30, 2024 · Recall initiated: September 25, 2024
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP violations
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fresenius Kabi Compounding, LLC
- Distributor
- Product was distributed to 125 direct accounts nationwide.
- Lot
- Lot # C274-000038499, exp. date 21-Dec-24
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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