Chloramphenicol 500 mg Amphotericin 50 mg Otic Powder packaged in jars, Rx Only, KRS Global Biote...
FDA Recall #D-0170-2018 — Class II — November 16, 2017
Product Description
Chloramphenicol 500 mg Amphotericin 50 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Reason for Recall
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.
Recalling Firm
KRS Global Biotechnology, Inc — Boca Raton, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
20 jars
Distribution
Nationwide in the USA, Bermuda, and New Zealand
Code Information
Lot: 08162017@32 BUD: 2/12/2018
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated