17,898 recalls, newest first
Reason Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Reason Failed Dissolution Specifications
Reason Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Reason Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Reason Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Reason Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Reason Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
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 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 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.