Prescription and over-the-counter medications
Regeneron Pharmaceuticals
Lack of Assurance of Sterility: Complaints of syringe breakage
Pyramids Wholesale
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Chemical Contamination: Product manufactured with ethanol API that contains methanol
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
FA Online
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this unapproved drug.
Aruba Aloe Balm N.V.
Chemical Contamination: Product manufactured with ethanol API that contains methanol
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Pyramids Wholesale
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Second Tokushima Factory, Otsuka Pharmaceutical Co.
Cross Contamination with Other Products
Pyramids Wholesale
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Pyramids Wholesale
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Second Tokushima Factory, Otsuka Pharmaceutical Co.
Cross Contamination with Other Products
CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Second Tokushima Factory, Otsuka Pharmaceutical Co.
Cross Contamination with Other Products
Pyramids Wholesale
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Pyramids Wholesale
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Pyramids Wholesale
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Pyramids Wholesale
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.