FDA Recalls Itraconazole and Mupirocin Nasal Spray Due to Sterility Concerns
Well Care Compounding Pharmacy is recalling Itraconazole 0.2%/Mupirocin 0.2% Nasal Spray because FDA inspections found GMP violations that may affect sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in a compounded pharmaceutical product, which aligns with the criteria for Severe severity.
Plain-English summary
Well Care Compounding Pharmacy in Las Vegas, Nevada, is recalling 916 units of Itraconazole 0.2%/Mupirocin 0.2% Nasal Spray. The product is a prescription-only nasal spray distributed in Nevada.
The recall was initiated after FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product. The source text does not report any specific illnesses or injuries associated with the use of this product.
Patients who have received this medication should contact their healthcare provider for further instructions. The recall covers specific lots with expiration dates ranging from June 2016 to November 2016.
The recalled product
- Product
- ITRACONAZOLE 0.2%/MUPIROCIN 0.2% NASAL SPRAY; 30 mL Spray, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Manufacturer
- Well Care Compounding Pharmacy
- Category
- Drug — Compounded Prescription
- 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 (14)
- Lot #: 01042016:74@36
- Exp. 07/03/2016
- Lot #: 01052016:14@12
- Exp.06/18/2016
- Lot #: 01272016:70@17
- Exp. 07/25/2016
- Lot #:02222016:62@12
- Exp.08/24/2016
- Lot #:03212016:57@30
- Exp. 09/17/2016
- Lot #: 04182016:42@44
- Exp.10/16/2016
- Lot #:05012016:18@29
- Exp.11/01/2016.
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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