FDAFDA · Food and drugs·Recall number D-0171-2018
Chloramphenicol 500 mg Sulfamethoxazole 500 mg Amphotericin 50 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Published January 17, 2018 · Recall initiated: November 16, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- KRS Global Biotechnology, Inc
- Distributor
- Nationwide in the USA, Bermuda, and New Zealand
- Lot
- Lots: 07282017@24 BUD: 1/24/2018; 08162017@33 BUD: 2/12/2018
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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