Other Drugs

CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.

CGMP Deviations: products were stored outside the drug label specifications.

CGMP Deviations: products were stored outside the drug label specifications.

CGMP Deviations: products were stored outside the drug label specifications.

CGMP Deviations: products were stored outside the drug label specifications.

CGMP Deviations: products were stored outside the drug label specifications.

CGMP Deviations: products were stored outside the drug label specifications.

CGMP Deviations: products were stored outside the drug label specifications.

Labeling: Missing label: the product tube was missing a label and contained a different formulation.

Failed Dissolution Specifications

Failed Dissolution Specifications

Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain microbial contamination identified as Providencia rettgeri.

Defective Container: Product may leak when squeezed or when not in an upright position determined to be due to defects in the bottle neck finish and insufficient tightening.

Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.

Microbial contamination of non-sterile product.

cGMP deviations: Temperature abuse

Lack of Assurance of Sterility

cGMP deviations: Temperature abuse

Microbial contamination of non-sterile product.

cGMP deviations: product stored outside of labeled temperature requirements.