Showing 12 of 161 records
Page 1 of 14Kenil Healthcare Private Limited
Cura Hongos, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 FL OZ (22.5 ML) Bottle, Dist…
CGMP Deviations
Blemfree
All Day Lotion (Salicylic Acid 0.5% W/w), Packaged in a) 1 OZ
CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
Seatex LLC
Problend Antibacterial Foaming Silk All-in-one Foaming Hand Sanitizer & Cleanser, Benzalkonium…
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Seatex LLC
Problend E3 Foaming Hand Sanitizer, All-in-one Foaming Hand Sanitizer & Cleanser, Seatex LLC, …
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Cabtreo
(Clindamycin Phosphate, Adapalene and Benzoyl Peroxide) Topical Gel 1.2%/0.15%/3.1%, Not For…
CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining…
Secret Antiperspirant
Secret, Powder Fresh, (Aluminum Chlorohydrate 24%), Anti-perspirant/deodorant, Topical Spray…
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
The Procter & Gamble Company
Old Spice, Pure Sport, (Aluminum Chlorohydrate 23.5%), Anti-perspirant & Deodorant Spray, …
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Justified Laboratories
Skincell Mole & Skin Corrector Serum, 1 FL
Marketed Without An Approved NDA/ANDA; Unapproved new drug
Justified Laboratories
Skincell Mole & Skin Corrector Serum, 1 FL
Marketed Without An Approved NDA/ANDA; Unapproved new drug
Aire-master of America INC
Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 Fl/oz
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Aire-master of America INC
Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutions, LLC, 344-5…
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Aire-master of America INC
Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 ML (33.9 FL
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
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