CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
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.
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Subpotent Drug: FDA analysis found product to be subpotent
Chemical Contamination: HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, was found to be below the label claim for ethanol content and contained methanol.
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
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: products were recalled because they were manufactured in the same facility as the product found to contain methanol.
BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), 16.9 FL OZ (500 mL) bottle, UPC 8 40038 21456 3, Made in Mexico; Distributed by Scent Theory Products, LLC, New York, NY 10018.
Real Clean Distribuciones SA de CV
Class I - Dangerous
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.
LUX EOI Hand Sanitizing Gel, (Ethyl Alcohol 70%), (16.9 FL OZ) 500mL bottle, Distributed by: Procurement Services, LLC Nashville, TN 37215, Product of Mexico. NDC 74882-007-02
Real Clean Distribuciones SA de CV
Class I - Dangerous
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.
BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), packaged as a) 9.5 FL OZ (280 mL) bottle, UPC 8 40038 21462 4: b) 16.9 FL OZ (500 mL) bottle, UPC 8 40038 21456 3; and c) 34 FL OZ (1L) bottle, UPC 8 40038 21447 1; Made in Mexico; Distributed by Scent Theory Products, LLC, New York, NY 10018.
Real Clean Distribuciones SA de CV
Class I - Dangerous
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.
Class I - Dangerous
Subpotent Drug: FDA analysis found product to be subpotent