Loading...
Loading...
Browse drug and medication recalls including prescription drugs, OTC medications, and supplements. Stay informed about pharmaceutical safety alerts.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Presence of Particulate Matter.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Lack of Assurance of Sterility: Firm did not perform process validation.
Lack of Assurance of Sterility: Firm did not perform process validation.
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Failed Dissolution Specifications
Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Presence of Particulate Matter
CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
CGMP Deviations: Out of specification for residual solvents.
Failed Dissolution Specifications: results slightly under spec at at 9-months.
CGMP Deviations: potential presence of Burkholderia cepacia complex