Class II · Moderate risk Ongoing
Amphotericin B Liposome for Injection
Reason Out of specification for assay
Iodochlorhydroxyquin 3%/ Boric Acid 10%/ Amphotericin 5% Otic…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
What was recalled
Iodochlorhydroxyquin 3%/ Boric Acid 10%/ Amphotericin 5% Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
- Recalling firm
- KRS Global Biotechnology, Inc
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0182-2018
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 Amphotericin recalls
See all
Class II · Moderate risk Terminated
Amphotericin B Liposome for Injection
Reason Subpotent drug
Class II · Moderate risk Terminated
Abelcet
Reason Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
Class II · Moderate risk Terminated
CSF-HC Otic Insufflation Capsule
Reason CGMP Deviations
Class II · Moderate risk Terminated
CSF Otic Insufflation Capsule
Reason CGMP Deviations
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