FDA Drug recall D-1028-2016
ITRACONAZOLE 0.2%/MUPIROCIN 0.2%/TRIAMCINOLONE 0.03% NASAL SPRAY, 15mL bottle, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- FDA Drug
- Class II
- terminated
- Published 2016-06-15
On 2016-06-15 the FDA classified a Class II recall of ITRACONAZOLE 0.2%/MUPIROCIN 0.2%/TRIAMCINOLONE 0.03% NASAL SPRAY, 15mL bottle, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 by Well Care Compounding Pharmacy, citing lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1028-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-17 |
| Published | 2016-06-15 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Well Care Compounding Pharmacy |
| Distribution | NV |
Product
ITRACONAZOLE 0.2%/MUPIROCIN 0.2%/TRIAMCINOLONE 0.03% NASAL SPRAY, 15mL bottle, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Reason
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Identifiers
| code_info | Lot #: 02102016:22@57, Exp. 08/08/2016; Lot #: 02292016:59@55 ,Exp. 08/28/2016; Lot #: 03072016:68@7, Exp. 09/03/2016…Lot #: 02102016:22@57, Exp. 08/08/2016; Lot #: 02292016:59@55 ,Exp. 08/28/2016; Lot #: 03072016:68@7, Exp. 09/03/2016; Lot #: 4052016:41@56, Exp. 10/04/2016; Lot #: 04192016:41@34, Exp.10/16/2016. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1028-2016%22
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