Other Drugs

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

Labeling Not Elsewhere Classified: Product labeled to contain methanol

Labeling: Label Error on Declared Strength

Labeling Not Elsewhere Classified: Product labeled to contain methanol

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.

cGMP Deviations

Labeling Not Elsewhere Classified: Product labeled to contain 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

CGMP Deviation: Potential contamination with undeclared methanol.

CGMP Deviations

cGMP deviations