8.4% Sodium Bicarbonate Injection
Presence of Particulate Matter: Silicone
231 recalls · Class I, newest first
Presence of Particulate Matter: Silicone
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found in an FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
Non-Sterility
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
Non-Sterility
Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits.
Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Chemical Contamination: FDA analysis found 1 lot of Adam's Polishes ALCOHOL BASED HAND SANITIZER isopropyl alcohol 75% v/v to contain methanol.
Chemical contamination: presence of benzene
Chemical contamination: Presence of benzene
Chemical contamination: Presence of benzene
Chemical contamination: Presence of benzene
Superpotent Drug
Superpotent Drug
Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil
Chemical Contamination: presence of benzene
Chemical Contamination: presence of benzene