The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1028-2016·Announced 2016-06-15

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.

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 3/5 (High).

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.

See all 51 products in this recall →

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