Drugs Recalls

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.

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

Subpotent Drug: FDA analysis found product 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.

Subpotent Drug: FDA analysis found product to be subpotent

Subpotent Drug: FDA analysis found product to be subpotent

CGMP Deviations: Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.

Labeling Not Elsewhere Classified: Product labeled to contain methanol

CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.

Labeling: Label Error on Declared Strength

Labeling Not Elsewhere Classified: Product labeled to contain methanol

Sub-Potent Drug: Out of specification test results for potency (below specification).

CGMP Deviations: Products manufactured at the same site were FDA testing found below the label claim for ethanol content and the presence of undeclared methanol.

Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug

Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug

Subpotent drug

cGMP deviations

Chemical Contamination: Product contains methanol.