FDAFDA · Food and drugs·Recall number D-1027-2016
ITRACONAZOLE 0.2%/MUPIROCIN 0.2% NASAL SPRAY; 30 mL Spray, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Published June 15, 2016 · Recall initiated: May 17, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Well Care Compounding Pharmacy
- Distributor
- NV
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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