Class I - Dangerous
Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label.
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Other Drugs
💊 Drugs • 3,200 recalls
Class I - Dangerous
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.
Class I - Dangerous
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.
Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces per carton, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-3328-3.
P & L Developments
Class I - Dangerous
Labeling: Incorrect or Missing Package Insert: The package insert included in the finished product is for the Canadian market and is not part of the current approved drug labeling.
Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
Class I - Dangerous
Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
Class I - Dangerous
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.
pH-D Feminine Health Boric Acid Vaginal Suppositories, 24 vaginal suppositories per box, 600 mg each, pH-D Feminine Health, LLC Madison, TN 37115, UPC Code: 3 49597 00044 5.
pH-D Feminine Health
Class I - Dangerous
Marketed without an Approved NDA/ANDA.
Class I - Dangerous
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.
Class I - Dangerous
Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
Class I - Dangerous
Defective Delivery System: Sustained trend of failure to dispense complaints.
Class I - Dangerous
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.
Class I - Dangerous
GMP Deviations: Potential to contain 1-propanol.
Class I - Dangerous
GMP Deviations: Potential to contain 1-propanol.
Class I - Dangerous
Chemical Contamination: Product contains methanol as an active ingredient and is sub-potent for ethanol.
scent theory KEEP CLEAN Moisturizing Hand Sanitizer, 70% alcohol (Ethyl Alcohol 70%), 16.9 FL OZ/500 mL bottle, Distributed by Scent Theory Products, LLC New York, NY 10018. Made in Mexico, UPC 8 40038 21434 1
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.
Goldenseal Root Powder Organic, 1 oz. clear plastic bag, Maison Terre Natural Products, www.maisonterre.net
Maison Terre
Class I - Dangerous
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.