💊 Drugs • 11,927 recalls
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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.
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.
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.
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
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.
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.
Glenmark Pharmaceuticals Inc., USA
Failed Dissolution Specifications
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
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.
Specialty Process Labs
Failed Stability Specifications
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
CGMP Deviations
Specialty Process Labs
Failed Stability Specifications
Failed Impurities/Degradation Specifications
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.