FDA Drug recall D-0169-2018
Chloramphenicol 50 mg/ Sulfamethoxazole 50 mg/ Amphotericin-B 5 mg capsules, For OTIC Use Only, 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 50 mg/ Sulfamethoxazole 50 mg/ Amphotericin-B 5 mg capsules, For OTIC Use Only, 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-0169-2018 |
| 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 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.
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 | Lot: 08212017@24 BUD: 2/17/2018 |
|---|
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-0169-2018%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.