Class III · Low risk
Dots Scented Antibacterial Hand Gel Strawbrry
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
FDA Drug Recalls
152 recalls · Class III, newest first
Class III · Low risk
Dots Scented Antibacterial Hand Gel Lime
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Dots Scented Antibacterial Hand Gel Orange
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Tootsie Roll POP RASPBERRY 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 POP CHOCOLATE 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 POP ORANGE SCENTED ANTIBACTERIAL HAND GEL
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Texas Home Health Home Care Hospice Personal Care Hand Sanitizer
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
festpak clearly fun SPF30 sunscreen lotion SPF 30 SUNSCREEN…
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
SPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Tootsie Roll POP GRAPE SCENTED ANTIBACTERIAL HAND GEL
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Good to Go Hand Sanitizer
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Accent Care of New York Home Care Nursing Personal Care Hand Sanitizer
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Telmisartan and Amlodipine Tablets 80 mg/5 mg
Failed Impurities/Degradation Specifications; 18 month long term stability study.
Class III · Low risk
Clonidine HCL Injection
Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL.
Class III · Low risk
Nystatin Oral Suspension
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Class III · Low risk
Thallous Chloride TI 201 Injection
Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product.
Class III · Low risk
Biotin 10 mg/mL Injection
Failed pH Specification: product does not meet pH label claim.
Class III · Low risk
Diclofenac Sodium Topical Solution
Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
Class III · Low risk
Repairwear Laser Focus Line Smoothing Cream Broad Spectrum SPF 15
Defective container: Ineffective seal between the cap and jar of the affected product.
Class III · Low risk
Clindamycin Injection
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk
Clindamycin Injection
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk
Clindamycin Injection
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk
Cleocin Phosphate
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk
Cleocin Phosphate
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk
Cleocin Phosphate
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point