Phenylephrine HCl 0 recalled over manufacturing violations
- Recall date
- September 25, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Fresenius Kabi Compounding, LLC recalls Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Servic…
- Recall number
- D-0017-2025
- FDA classification
- Class II
- Brand / firm
- Fresenius Kabi Compounding, LLC
- Sold / distributed
- Product was distributed to 125 direct accounts nationwide.
Why it was recalled
cGMP violations
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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