Prescription and over-the-counter medications
Optikem International
Lack of Assurance of Sterility
Optikem International
Lack of Assurance of Sterility
Optikem International
Lack of Assurance of Sterility
Optikem International
Lack of Assurance of Sterility
Optikem International
Lack of Assurance of Sterility
Failed Stability Specifications: Out of specification for blend uniformity.
Optikem International
Lack of Assurance of Sterility
Optikem International
Lack of Assurance of Sterility
Optikem International
Lack of Assurance of Sterility
Contract Pharmaceuticals Limited Canada
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Failed Dissolution Specifications
Failed Dissolution Specifications: results slightly under spec at at 9-months.
Contract Pharmaceuticals Limited Canada
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
SUN PHARMACEUTICAL INDUSTRIES
Failed Dissolution Specifications: Out of specification for dissolution.
Golden State Medical Supply
CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Denver Solutions, LLC
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Lack of Assurance of Sterility
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.