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.
FDA Drug Recalls
18,003 recalls, newest first
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.
Class III · Low risk
Dots Scented Antibacterial Hand Gel Lemon
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
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.
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 II · Moderate risk
Pantoprazole Sodium Delayed-Release Tablets
Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.
Class I · High risk
Lidocaine HCl Injection
Presence of Particulate Matter: One vial was found to contain a hair.
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 II · Moderate risk
Phenobarbital Oral Solution
Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Class II · Moderate risk
Bismuth Subsalicylate Oral Suspension 262mg/15mL
Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Class II · Moderate risk
Pravastatin Sodium Tablets USP
Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
Class II · Moderate risk
Testosterone Cypionate Injection
Presence of Particulate Matter.