Class III · Low risk Ongoing
Levocarnitine Injection
Reason Labeling: Missing Label
L-Carnitine 27 mL Fill in a 30 mL Vial
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
What was recalled
L-Carnitine 27 mL Fill in a 30 mL Vial, For Dilution Use Only, 2,025 mg/27 mL (75 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676396
- Recalling firm
- KRS Global Biotechnology, Inc
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0045-2020
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Carnitine recalls
See all
Class II · Moderate risk Ongoing
Lipo MIC + L-Carnitine for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
L-Carnitine for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
LX Bioboost Plus
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Levocarnitine Oral Solution
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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