HONEY MANUKA BUNNY LOVE, 12g, All Natural Sexual Enhancement, UPC: N/A
Pyramids Wholesale
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Prescription and over-the-counter medications
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.
CGMP Deviations
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.
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.
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.
Pyramids Wholesale
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
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.
Amneal Pharmaceuticals of New York
Superpotent Drug: Due to overfilling of drug powder
CGMP Deviations