Drugs Recalls

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%.

Lack of assurance of sterility.

Lack of assurance of sterility.

Lack of assurance of sterility.

Lack of assurance of sterility.

Lack of assurance of sterility.

CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.

Lack of assurance of sterility.

Lack of assurance of sterility.

Lack of assurance of sterility.

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

Lack of assurance of sterility.

Lack of assurance of sterility.

Lack of assurance of sterility.

Lack of assurance of sterility.

Lack of assurance of sterility.

Lack of assurance of sterility.

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

Lack of assurance of sterility.

Lack of assurance of sterility.