Drugs Recalls

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.

Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator

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.

Lack of sterility assurance.

Lack of sterility assurance.

Lack of sterility assurance.

Lack of sterility assurance.

Lack of sterility assurance.