Other Drugs

cGMP deviations: product stored outside of labeled temperature requirements.

cGMP deviations: product stored outside of labeled temperature requirements.

cGMP deviations: product stored outside of labeled temperature requirements.

cGMP deviations: product stored outside of labeled temperature requirements.

cGMP deviations: product stored outside of labeled temperature requirements.

cGMP deviations: product stored outside of labeled temperature requirements.

Superpotent Drug: product complaint for milky blue appearance and consistency, further investigation by the firm found the recalled lots out of specification for the four active ingredients.

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.

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%.

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Microbial Contamination of Non-Sterile Products

Microbial Contamination of Non-Sterile Products

CGMP Deviations: Failure to properly investigate failed microbial testing.

CGMP Deviations: Failure to properly investigate failed microbial testing.

Chemical Contamination; FDA analysis found product to contain methanol

Chemical Contamination; FDA analysis found product to contain benzene

Chemical contamination: presence of benzene

Incorrect/Undeclared Excipient: Product contains alcohol

CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene