cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
All Recalls
95,018 total recalls in our database
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Microbial Contamination of Non-Sterile Products.
Microbial Contamination of Non-Sterile Products.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Microbial Contamination of Non-Sterile Products
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Microbial Contamination of Non-Sterile Products.