US Drug Recall Register
Class II · Moderate risk Terminated Initiated Nov 16, 2017 (9 years ago)

Chloramphenicol 50 mg/ Sulfamethoxazole 50 mg/ Amphotericin-B 5 mg capsules, For OTIC Use…

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

Chloramphenicol 50 mg/ Sulfamethoxazole 50 mg/ Amphotericin-B 5 mg capsules, For OTIC Use Only, 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-0169-2018

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.

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