Prescription Drugs

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve sample vials

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes