Class II · Moderate risk Ongoing
GreenScreen, kabana organic skincare, Bread Spectrum UVA & UVB, Zinc Oxide Sunscreen, Organic Ingredients, Fragrance Free…
Reason cGMP deviations
Is Fragrance recalled?
17 FDA recalls mention Fragrance. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Fragrance.
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
Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U…
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.
Class II · Moderate risk Terminated
Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per plastic carton, Manufactured for B4 Brands…
Reason CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II · Moderate risk Terminated
Avant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) 1000 mL (33.9 fl. oz.) pouch, c) 55 gallon drum…
Reason CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II · Moderate risk Ongoing
Aveeno Daily Moisturizing lotion Fragrance Free with Soothing Oat & Rich Emollients, Net Wt. 5 oz (141 g), Distributed by Johnson…
Reason cGMP deviations: product stored outside of labeled temperature requirements.
Class II · Moderate risk Terminated
Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 50, packaged in a) 1.5 fl…
Reason Microbial contamination of non-sterile products: positive test for yeast and bacteria.
Class II · Moderate risk Terminated
Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 30, package in 1.5 fl. oz…
Reason Microbial contamination of non-sterile products: positive test for yeast and bacteria.
Class II · Moderate risk Terminated
Unison Hand Care Products, WHITE PEARLIZED Anti-Bacterial Hand Cleaner with Triclosan, #4302, with exclusive Bajan fragrance…
Reason CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk Terminated
alba BOTANICA Sensitive Sheer Shield Sunscreen Fragrance Free spf 50+ , 85 g 3 oz tube. Manufactured by: The Haine Celestial…
Reason Microbial Contamination of a Non-Sterile Product
Class I · High risk Terminated
Dr. King's SafeCare Rx Allergies: Fragrances & Phenolics, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC…
Reason Microbial contamination
Class I · High risk Terminated
Dr. King's Natural Medicine Homeopathic Fragrance & Phenolic Allergy Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr…
Reason Microbial contamination
Class II · Moderate risk Terminated
Fagron, Pentravan Plus Base 2.5 Kg, Article number: 804749. RX only, For prescription compounding, Oil-in-water emulsion base…
Reason Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
Class II · Moderate risk Terminated
Fagron, Pentravan Base 2.5 Kg, Article number: 802486. RX only, For prescription compounding, Oil-in-water emulsion, PLO gel…
Reason Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
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