CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
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Other Drugs
💊 Drugs • 3,313 recalls
Class I - Dangerous
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Zapien Productos Hand Sanitizer Gel Antibacterial, 33.8 FL. OZ (1000 mL), Made by GAZA S.A. DE C.V. Castilla St. #1473-A ZIP 45410 Tonala, Jalisco, Mexico, UPC: 7 501700 623504, NDC numbers: 76938-001-01, 76938-001-02, 76938-001-03.
GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION
Class I - Dangerous
cGMP deviations: Product made at the same facility where product tested was sub-potent.
Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing, 8.45 Fl. Oz. (250 mL) Bottle, Distributed by: Universal Distributors LLC, 6197 S. Rural Rd.,Tempe AZ, 85283, Made in Mexico by: Gaza Proveedora De Servicios De Hospedaje y Alimentos S.A. de C.V., UPC 8 64972 00049 5, NDC 76540-100-02
GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION
Class I - Dangerous
cGMP deviations: Product made at the same facility where product tested was sub-potent.
Happy Ducts Compress, 3 oz. plastic jar, www.wishgardenherbs.com, Boulder, CO. 80301. UPC 6 56490 20223 5
Wishgarden Herbs, Incorporated
Class I - Dangerous
Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
Goldenseal POWDER, 0.25 oz. (7 g) plastic jars, WishGarden Herbs, Inc., Boulder, CO 80301. UPC 6 56490 64137 9
Wishgarden Herbs, Incorporated
Class I - Dangerous
Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
Cord Care POWDER, 0.25 oz. (7 g) plastic jars, Wishgarden Herbs, Inc., Boulder, CO 80301. UPC 6-56490 24730 4
Wishgarden Herbs, Incorporated
Class I - Dangerous
Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
Kroger Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 0.5 OZ (15g), Distributed by The Kroger Co. Cincinnati, Ohio 45202 Made in Canada. NDC 30142-305-01
Taro Pharmaceuticals U.S.A.
Class I - Dangerous
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
BPC-157, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Advanced Nutriceuticals
Class I - Dangerous
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
GHRP, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Advanced Nutriceuticals
Class I - Dangerous
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
TopCare Health, Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT. 0.5 oz. (14.2 g). Distributed by Topco Associates LLC, Elk Grove Village, IL 60007. NDC 36800-495-69 UPC 0 36800 49569 2
Taro Pharmaceuticals U.S.A.
Class I - Dangerous
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
THYMOSIN ALPHA, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Advanced Nutriceuticals
Class I - Dangerous
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
LL-37, 2000 MCG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Advanced Nutriceuticals
Class I - Dangerous
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
AOD-9604, 1200 MCG/ML, 5 ML vial The Guyer Institute of Molecular Medicine, Indianapolis, IN
Advanced Nutriceuticals
Class I - Dangerous
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
CEREBROLYSIN, 107.5 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Advanced Nutriceuticals
Class I - Dangerous
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Kroger Jock Itch Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT .5 OZ (15 g), Distributed by The Kroger CO, Cincinnati, Ohio 45202 Made in Canada, NDC 30142-510-01
Taro Pharmaceuticals U.S.A.
Class I - Dangerous
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
THYMOSIN BETA - 4, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Advanced Nutriceuticals
Class I - Dangerous
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
HIGH DOSE B12, 10 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Advanced Nutriceuticals
Class I - Dangerous
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
CJC-1295, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Advanced Nutriceuticals
Class I - Dangerous
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
CitruGel Hand Sanitizer Advanced Formula 70% Alcohol Fresh Lemon Scent, 33.81 FL OZ (1L), Distributed By Citru Gel Inc. Henderson, NV 89052 www.citrugel.com NDC: 78247-002-01
Simex Logistics SA de CV
Class I - Dangerous
Subpotent drug