Drugs Recalls

CGMP deviations

cGmp Deviations

Labeling: Label Mix-Up-The primary label on the front of the bottles have 50% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide, Topical Solution USP with active ingredient Hydrogen Peroxide (stabilized) 3%, 32 FL Ounces. The back label is correct. Product is packaged in dark bottles.

Failed impurities/degradation specifications

Labeling - product contains undeclared ethyl alcohol

cGMP deviations

CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center.

Labeling - product contains undeclared ethyl alcohol

Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

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

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.