FDA Drug recall D-0171-2018
Chloramphenicol 500 mg Sulfamethoxazole 500 mg Amphotericin 50 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park…
- FDA Drug
- Class II
- terminated
- Published 2018-01-17
On 2018-01-17 the FDA classified a Class II recall of Chloramphenicol 500 mg Sulfamethoxazole 500 mg Amphotericin 50 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park… by Krs Global Biotechnology, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0171-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-16 |
| Published | 2018-01-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Krs Global Biotechnology |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | Lots: 07282017@24 BUD: 1/24/2018; 08162017@33 BUD: 2/12/2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0171-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.