557 recalls, newest first
Reason CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Reason CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Reason Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL…
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 Failed Impurities/Degradation Specifications: Out-of-specification test results.
Reason Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the…
Reason CGMP Deviations: Out of specification for residual solvents.
Reason CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment…
Reason Failed Stability Specifications: Out of specification for blend uniformity.
Reason Failed Dissolution Specifications: results slightly under spec at at 9-months.
Reason CGMP Deviations: potential presence of Burkholderia cepacia complex
Reason an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product…
Reason cGMP Deviations: Products were stored outside the drug label specifications.
Reason cGMP Deviations: Products were stored outside the drug label specifications.
Reason cGMP Deviations: Products were stored outside the drug label specifications.
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 Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Reason Failed Dissolution Specifications: Out of specification for dissolution.
Reason Labeling: Incorrect or Missing Package Insert