💊 Drugs • 3,313 recalls
pH-D Feminine Health
Marketed without an Approved NDA/ANDA.
CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
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.
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.
Real Clean Distribuciones SA de CV
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.
Maison Terre
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.
Chemical Contamination: HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, was found to be below the label claim for ethanol content and contained methanol.
CGMP Deviations: products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Real Clean Distribuciones SA de CV
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.
Real Clean Distribuciones SA de CV
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.
Real Clean Distribuciones SA de CV
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.
Real Clean Distribuciones SA de CV
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
Edge Pharma
Labeling: Label Error on Declared Strength
Labeling Not Elsewhere Classified: Product labeled to contain methanol