Class II · Moderate risk Ongoing
Killz Germz Hand Sanitizer
Reason Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol levels as low as 62% while labelled claim is 70%.
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Ongoing
Genesis Hand Sanitizer Gel
Reason CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.
Class II · Moderate risk Ongoing
Genesis Hand Sanitizer Gel
Reason CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.
Class II · Moderate risk Ongoing
Panagel Hand Sanitizer
Reason CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.
Class I · High risk Terminated
M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v
Reason Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and below label claim for ethanol.
Class III · Low risk Terminated
Citalopram Oral Solution
Reason Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint
Class III · Low risk Terminated
Nicotine Gum
Reason 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.
Class II · Moderate risk Terminated
Buprenorphine Transdermal System 5 mcg/hour
Reason Failed Stability Specifications: Below specification result for buprenorphine release rate.
Class II · Moderate risk Terminated
Eye Itch Relief
Reason CGMP Deviations
Class II · Moderate risk Terminated
bio aaa Alcohol en Gel Antibacterial
Reason CGMP Deviations: Product manufactured in a facility where methanol was found in other distributed lots of product.
Class I · High risk Terminated
Leafree Instant Hand Sanitizer Aloe Vera
Reason Marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol rendering the product an unapproved new drug and misbranded.
Class II · Moderate risk Terminated
pH-D Feminine Health Boric Acid Vaginal Suppositories
Reason Marketed without an Approved NDA/ANDA.
Class II · Moderate risk Terminated
Nature-Throid
Reason CGMP Deviations
Class II · Moderate risk Terminated
Nature-Throid
Reason CGMP Deviations
Class II · Moderate risk Terminated
Nature-Throid
Reason CGMP Deviations
Class II · Moderate risk Terminated
Nature-Throid
Reason CGMP Deviations
Class II · Moderate risk Terminated
Hand Sanitizer
Reason CGMP Deviations: Product contains acetaldehyde and acetal above the allowable limits.
Class II · Moderate risk Terminated
Hand Sanitizer
Reason CGMP Deviations: Product manufactured in same facility where product was found to contain acetaldehyde and acetal above the allowable limits.
Class I · High risk Terminated
Red-E Tablet
Reason Marketed Without An Approved NDA/ANDA: product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug fro which the safety and efficacy have not been established and therefore subject to recall.
Class I · High risk Terminated
Nature Throid
Reason Subpotent Drug: FDA analysis found product to be subpotent
Class I · High risk Terminated
Nature Throid
Reason Subpotent Drug: FDA analysis found product to be subpotent
Class I · High risk Terminated
Nature Throid
Reason Subpotent Drug: FDA analysis found product to be subpotent
Class I · High risk Terminated
Nature Throid
Reason Subpotent Drug: FDA analysis found product to be subpotent
Class I · High risk Terminated
Nature Throid
Reason Subpotent Drug: FDA analysis found product to be subpotent
Class I · High risk Terminated
WP Thyroid
Reason Subpotent Drug: FDA analysis found product to be subpotent