The Recall Desk
SevereFDA (Drugs)·D-1027-2016·Announced 2016-06-15

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.

What this means for you

Illness, injury, or structural failure has been reported. 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.

See all 51 products in this recall →

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Same hazard · sterility

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