Recalls / Class II
Class IID-1027-2016
Product
ITRACONAZOLE 0.2%/MUPIROCIN 0.2% NASAL SPRAY; 30 mL Spray, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Affected lot / code info
- 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.
Why it was recalled
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Recalling firm
- Firm
- Well Care Compounding Pharmacy
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 3430 E Tropicana Ave Ste 9, N/A, Las Vegas, Nevada 89121-7345
Distribution
- Quantity
- 916 total units
- Distribution pattern
- NV
Timeline
- Recall initiated
- 2016-05-17
- FDA classified
- 2016-06-09
- Posted by FDA
- 2016-06-15
- Terminated
- 2017-01-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1027-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.