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Fresenius Kabi Compounding, LLC

FDA Regulatory Profile

Summary

Total Recalls
15
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0337-2026Class IIvancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron SterilFebruary 5, 2026
D-0333-2026Class IIacyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, For IntravenouFebruary 5, 2026
D-0335-2026Class IIthiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile SeFebruary 5, 2026
D-0336-2026Class IIvancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron StFebruary 5, 2026
D-0334-2026Class IIketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron SterFebruary 5, 2026
D-0016-2025Class IIPhenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, FaSeptember 25, 2024
D-0020-2025Class IINORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx oSeptember 25, 2024
D-0021-2025Class IIOxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron StSeptember 25, 2024
D-0019-2025Class IINORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx oSeptember 25, 2024
D-0014-2025Class IIPhenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, FaSeptember 25, 2024
D-0018-2025Class IIVancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, FagroSeptember 25, 2024
D-0015-2025Class IIPhenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, FaSeptember 25, 2024
D-0023-2025Class IIThiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, FagronSeptember 25, 2024
D-0017-2025Class IIPhenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, FaSeptember 25, 2024
D-0022-2025Class IIEPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron SteSeptember 25, 2024