Class II · Moderate risk Ongoing
GreenScreen, kabana organic skincare, Bread Spectrum UVA & UVB, Zinc Oxide Sunscreen, Organic Ingredients, Fragrance Free…
Reason cGMP deviations
Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.)…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
What was recalled
Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tampa 33606.
- Recalling firm
- Aire-Master of America Inc
- Origin
- MO, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1358-2022
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 Fragrance recalls
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Class II · Moderate risk Ongoing
babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658…
Reason Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was…
Class II · Moderate risk Terminated
Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutions, LLC, 344-5 Route 9, Suite 237, Lanoka Harbor, NJ…
Reason CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II · Moderate risk Terminated
Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) per bottle, Manufactured for Protect U Guard, Tampa…
Reason CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II · Moderate risk Terminated
Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2…
Reason CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
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