1,018 recalls, newest first
Mislabeling: The active ingredient list on the label does not match the product's actual ingredients Specifically, the label states Octinoxate 7.5% and Oxybenzone 3%, while the product therein is made with Octinoxate 7.5%, Octisalate 5%, Octocrylene 5%, and Avobenzone 3%.
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Failed Dissolution Specifications: low out of specification results for dissolution.
Failed Dissolution Specifications: low out-of-specification dissolution test results observed.
Subpotent drug: Low OOS for menthol content at the three month room temperature.
Failed Stability Specification
CGMP Deviations
CGMP Deviations
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Subpotent drug
Subpotent drug
Failed Dissolution Specifications
Failed viscosity specification - product was below specificcation
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
cGMP Deviations