Prescription and over-the-counter medications
Aurobindo Pharma USA
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Labeling: Incorrect or missing Lot and/or Exp Date:The Kit is incorrectly labeled as expiring May 2018 however the correct expiration date is May 2019. In addition, device component (syringe) lacks 510(k) clearance.
Aurobindo Pharma USA
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Aurobindo Pharma USA
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
CGMP Deviation; manufacturing batch record could not be located
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Glenmark Pharmaceuticals Inc., USA
Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
Heritage Pharmaceuticals
Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
GMP Deviations: A silicone particulate was noted in Ozurdex.
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Subpotent
Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
Hiers Enterprises, LLC
Lack of sterility assurance.
Hiers Enterprises, LLC
Lack of sterility assurance.