359 recalls, newest first
Reason Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL…
Reason Presence of Particulate Matter
Reason CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Reason CGMP Deviations: Out of specification for residual solvents.
Reason CGMP Deviations: potential presence of Burkholderia cepacia complex
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved…
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved…
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an ingredient found in FDA approved…
Reason cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Reason cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Reason Failed Dissolution Specifications: Out of specification for dissolution.
Reason Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Reason Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Reason Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the…
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Reason Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Reason Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the…
Reason Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
Reason Misprint on tablet
Reason Misprint on tablet
Reason Failed Impurities/Degradation Specification: Out of specification for organic impurities