Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops ALL-IN-ONE
Reason Lack of Assurance of Sterility
DermaZinc Spray
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent (Single Ingredient Drug): The firm is recalling the product because the product is subpotent and does not meet the labeled 0.25% zinc pyrithione level.
What was recalled
DermaZinc Spray, 0.25% zinc pyritione, topical OTC, 4 fl oz bottle Distributed By: Dermallogix Partners, Inc. Scarborough, ME 04070
- Recalling firm
- Quadrant Chemical Corporation
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1380-2012
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.
Other Zinc recalls
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Class II · Moderate risk Ongoing
Med Pride
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk Ongoing
Med Pride
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk Ongoing
Med Pride
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk Ongoing
Med Pride
Reason CGMP Deviations; deficiencies observed during FDA inspection
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