Class III · Low risk
Citalopram Oral Solution
Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint
FDA Drug Recalls
14,806 recalls, newest first
Class III · Low risk
Nicotine Gum
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
Buprenorphine Transdermal System 5 mcg/hour
Failed Stability Specifications: Below specification result for buprenorphine release rate.
Class II · Moderate risk
Eye Itch Relief
CGMP Deviations
Class II · Moderate risk
bio aaa Alcohol en Gel Antibacterial
CGMP Deviations: Product manufactured in a facility where methanol was found in other distributed lots of product.
Class I · High risk
Leafree Instant Hand Sanitizer Aloe Vera
Marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol rendering the product an unapproved new drug and misbranded.
Class II · Moderate risk
pH-D Feminine Health Boric Acid Vaginal Suppositories
Marketed without an Approved NDA/ANDA.
Class II · Moderate risk
Nature-Throid
CGMP Deviations
Class II · Moderate risk
Nature-Throid
CGMP Deviations
Class II · Moderate risk
Nature-Throid
CGMP Deviations
Class II · Moderate risk
Nature-Throid
CGMP Deviations
Class II · Moderate risk
Hand Sanitizer
CGMP Deviations: Product contains acetaldehyde and acetal above the allowable limits.
Class II · Moderate risk
Hand Sanitizer
CGMP Deviations: Product manufactured in same facility where product was found to contain acetaldehyde and acetal above the allowable limits.
Class I · High risk
Red-E Tablet
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
Nature Throid
Subpotent Drug: FDA analysis found product to be subpotent
Class I · High risk
Nature Throid
Subpotent Drug: FDA analysis found product to be subpotent
Class I · High risk
Nature Throid
Subpotent Drug: FDA analysis found product to be subpotent
Class I · High risk
Nature Throid
Subpotent Drug: FDA analysis found product to be subpotent
Class I · High risk
Nature Throid
Subpotent Drug: FDA analysis found product to be subpotent
Class I · High risk
WP Thyroid
Subpotent Drug: FDA analysis found product to be subpotent
Class II · Moderate risk
WP Thyroid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk
WP Thyroid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk
WP Thyroid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk
WP Thyroid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk
WP Thyroid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.