Showing 12 of 255 records
Page 8 of 22Sundial Herbal Products
Sundial Traditional Herbal Products***traditional Organic Herbs***chaney Root***2oz.***uses: …
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
Fantis Foods California, INC.
Fantis Pita 10 X 7" Pita Bread, 25 OZ
Individual product packaging does state Whey in ingredients but does not declare Milk as an allergen
Yusef Manufacturing Laboratories, LLC
Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradimate 5%, Octinoxate…
Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim.
Yusef Manufacturing Laboratories, LLC
Tropical Lip Moisturizer, SPF 30, Uva/uvb Lip Protection, Active Ingredients: Oxybenzone 5%, …
Superpotent Drug: The beginning portion of the batch appears to be approximately 25% superpotent for active ingredient Meradimate.
Allergan Plc
Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 OZ Bottle, Distributed in The…
SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
Allergan Plc
Skin Medica Acne System, Contains: Purifying Foaming Wash (Salicylic Acid 2.0%), 5 FL OZ
SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
Yusef Manufacturing Laboratories, LLC
Peppermint Lip Moisturizer (Oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g Tube, Labeled As…
Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for active ingredient Oxybenzone.
The Medicine Shoppe Pharmacy
Testosterone W/cosmetic Hrt Base 100 mg (10%) Cream 30 Gm, Tubes Rx, the Medicine Shoppe…
Lack of Processing Control
The Medicine Shoppe Pharmacy
Testosterone W/cosmetic Hrt Base 20 mg (2%) Cream 30 Gm Jar, Rx, the Medicine Shoppe Pharmacy, …
Lack of Processing Control
Filltech USA, LLC
Dermatone (Avobenzone, Homosalate, Octisalate, and Octocrylene) Sunscreen Lotion Fragrance…
Microbial contamination of non-sterile products: positive test for yeast and bacteria.
Filltech USA, LLC
Dermatone (Avobenzone, Homosalate, Octisalate, and Octocrylene) Sunscreen Lotion Fragrance…
Microbial contamination of non-sterile products: positive test for yeast and bacteria.
Herbal Doctor Remedies
Fungo Lotion, Distributed by Herbal Doctor Remedies Alhambra, Ca 91801-7081 USA, 1(800) 600-0808
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
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