FDA Recalls Itraconazole Nasal Spray Due to Sterility Concerns
Well Care Compounding Pharmacy is recalling Itraconazole/Mupirocin/Triamcinolone nasal spray because FDA inspections found GMP violations that may affect sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II due to GMP violations impacting sterility, which fits the rubric criteria for high-risk products where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Itraconazole 0.2%/Mupirocin 0.2%/Triamcinolone 0.03% Nasal Spray, 15mL bottles, manufactured by Well Care Compounding Pharmacy in Las Vegas, Nevada. The recall involves 916 total units distributed in Nevada. Specific lot numbers and expiration dates are listed in the agency's official recall notice.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility. The agency has classified this as a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Patients who have received this prescription medication should contact their healthcare provider or pharmacist for guidance on alternative treatments. Consumers should not use the recalled product until further notice.
The recalled product
- Product
- ITRACONAZOLE 0.2%/MUPIROCIN 0.2%/TRIAMCINOLONE 0.03% NASAL SPRAY, 15mL bottle, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Manufacturer
- Well Care Compounding Pharmacy
- Category
- Drug — Compounded Nasal Spray
- Hazard
- Affected units
- 916
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- 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.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 51 recalled by Well Care Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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