Class III · Low risk
Telmisartan and Amlodipine Tablets 80 mg/5 mg
Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
Class III drug recalls - low risk
Class III means the product is unlikely to cause harm but violates FDA labeling or manufacturing rules. These are the recalls you rarely hear about; pharmacies usually just swap the affected lot.
1,716 recalls, newest first.
Class III · Low risk
Remifentanil HCl active pharmaceutical ingredient
Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.
Class III · Low risk
Lemon Hand Sanitizer
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Dippin' Dots Scented Cotton Candy Antibacterial Hand Gel
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Dippin' Dots Scented Cookies 'N Cream Antibacterial Hand Gel
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Dippin' Dots Scented Birthday Cake Antibacterial Hand Gel
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Dippin' Dots Scented Banana Split Antibacterial Hand Gel
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Icee Blue Raspberry Scented Antibacterial Hand Gel
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Icee Cherry Scented Antibacterial Hand Gel
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Icee Peach Scented Antibacterial Hand Gel
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Icee Lemon Lime Scented Antibacterial Hand Gel
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Air Heads Orange Scented Antibacterial Hand Gel
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Air Heads Pink Lemonade Scented Antibacterial Hand Gel
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Air Heads Blue Raspberry Scented Antibacterial Hand Gel
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Air Heads Strawberry Scented Antibacterial Hand Gel
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Tootsie Roll Scented Antibacterial Hand Gel
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Tootsie Roll Fruit Chews Lime Scented Antibacterial Hand Gel
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Tootsie Roll Fruit Chews Vanilla Scented Antibacterial Hand Gel
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Tootsie Roll Fruit Chews Lemon Scented Antibacterial Hand Gel
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
AMERICA'S ORIGINAL DUBBLE BUBBLE Pink Lemonade SCENTED ANTIBACTERIAL HAND GEL
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
America's Original Dubble Bubble Scented Antibacterial Hand Gel
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Charms Blow Pop Sour Apple Scented Antibacterial Hand Gel
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Charms Blow Pop Blue Razz Berry Scented Antibacterial Hand Gel
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Charms Blow Pop Watermelon Scented Antibacterial Hand Gel
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Charms Blow Pop Cherry Scented Antibacterial Hand Gel
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.