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
14,450 recalls · Class II, newest first
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%.
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 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 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 II · Moderate risk Terminated
WP Thyroid
Reason CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk Terminated
WP Thyroid
Reason CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk Terminated
WP Thyroid
Reason CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk Terminated
WP Thyroid
Reason CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk Terminated
WP Thyroid
Reason CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk Terminated
WP Thyroid
Reason CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk Terminated
WP Thyroid
Reason CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk Terminated
WP Thyroid
Reason CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk Terminated
Nature-Throid
Reason CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk Terminated
Nature-Throid
Reason CGMP Deviations: manufactured under the same conditions as those found to be subpotent.