Prescription and over-the-counter medications
Consolidated Chemical
CGMP Deviations: initiated due to violations of CGMP manufacturing practices
Sentara Infusion Services
Lack of sterility assurance
Lack of sterility assurance
Sentara Infusion Services
Lack of sterility assurance
Sentara Infusion Services
Lack of sterility assurance
Sentara Infusion Services
Lack of sterility assurance
Amerisource Health Services
Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories.
Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
Urban Electric Power
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
cGMP Deviations
cGMP Deviations
cGMP Deviations
GFA Production Xiamen Co.
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
GFA Production Xiamen Co.
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
GFA Production Xiamen Co.
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
cGMP Deviations
cGMP Deviations
GFA Production Xiamen Co.
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.