Drugs Recalls

CGMP Deviations

cGMP Deviations

CGMP Deviations

Marketed Without An Approved NDA/ANDA: product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug fro which the safety and efficacy have not been established and therefore subject to recall.

Defective Delivery System: Sustained trend of failure to dispense complaints.

CGMP Deviations: Product manufactured in a facility where methanol was found in other distributed lots of product.

cGMP Deviations

CGMP Deviations

Marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol rendering the product an unapproved new drug and misbranded.

GMP Deviations: Potential to contain 1-propanol.

GMP Deviations: Potential to contain 1-propanol.

Chemical Contamination: Product contains methanol as an active ingredient and is sub-potent for ethanol.

CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Microbial Contamination of Non-Sterile Products: FDA laboratory analysis found product to be contaminated with various microorganisms including Enterobacter cloacae, Cronobacter sakazakii, Cronobacter dublinensis, among others.

CGMP Deviations: manufactured under the same conditions as those found to be subpotent.

CGMP Deviations: manufactured under the same conditions as those found to be subpotent.

CGMP Deviations: manufactured under the same conditions as those found to be subpotent.

CGMP Deviations: manufactured under the same conditions as those found to be subpotent.

CGMP Deviations: manufactured under the same conditions as those found to be subpotent.

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