209 recalls · Class II, newest first
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis from the brand product labeling not being incorporated into the Authorized Generic labeling.
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
Labeling; Product Contains Undeclared API (Oxybenzone)
Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.
Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label. The vial label and outer carton label contain the correct statement of 0.9% benzyl alcohol added as a preservative.
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Chemical Contamination: Naphthalene compound identified in the product after complaints of a petroleum odor.
Chemical contamination: Product may be contaminated with a toxic compound.
Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.
Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug.
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug.