Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
VORICONAZOLE 10MG/ML (10ML DROPPER) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
Reason Labeling: Incorrect or Missing Package Insert
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