Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OZ (13…
Reason Lack of Assurance of Sterility
DERMATONE (titanium oxide 6% and zinc oxide 4.7%) No-Touch Sunscreen Stick, SPF 50, Net…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Microbial Contamination of Non-Sterile Products: sample tested positive for Staphylococcus aureus.
What was recalled
DERMATONE (titanium oxide 6% and zinc oxide 4.7%) No-Touch Sunscreen Stick, SPF 50, Net Wt. 0.49 oz. (13.9g) stick, Distributed by: Beaumont Products, Inc. Kennesaw, GA 30144, UPC 0 20908 05100 3.
- Recalling firm
- Product Quest Manufacturing LLC
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0027-2019
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.
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Class II · Moderate risk Ongoing
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Reason CGMP Deviations; deficiencies observed during FDA inspection
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