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Lack of Assurance of Sterility
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
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.
CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
CGMP Deviations: Out of specification for residual solvents.
CGMP Deviations: potential presence of Burkholderia cepacia complex
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Failed Dissolution Specifications: Out of specification for dissolution.
CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.