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Recall Observatory FDA recall evidence

Drug product

ITRACONAZOLE 0.2%/MUPIROCIN 0.2%/TRIAMCINOLONE 0.03% NASAL SPRAY, 15mL bottle, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-1028-2016

May 17, 2016

Class II

Product summary

Firm
Well Care Compounding Pharmacy
Event
Event 74187
Status
Terminated
Classification
Class II
Quantity
916 total units
Official record key
drug-enforcement:D-1028-2016

Official wording

Reason: Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information: 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 pattern: NV

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    GMP violations
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility