Class II · Moderate risk
Zep, Alcohol Sanitizer Spray
Microbial contamination of sterile products
FDA Drug Recalls
2,357 recalls · Class II, newest first
Class II · Moderate risk
safco SensiCaine-Ultra
Defective container:may contain bottles with incomplete seals
Class II · Moderate risk
PureLife
Defective container:may contain bottles with incomplete seals
Class II · Moderate risk
Dental City TOPICAL ANESTHETIC GEL
Defective container:may contain bottles with incomplete seals
Class II · Moderate risk
Burkhart topical anesthetic gel
Defective container:may contain bottles with incomplete seals
Class II · Moderate risk
DHP Topical Anesthetic Gel
Defective container:may contain bottles with incomplete seals
Class II · Moderate risk
Quala Dental Products
Defective container:may contain bottles with incomplete seals
Class II · Moderate risk
Pearson Quality Topical Anesthetic Gel
Defective container:may contain bottles with incomplete seals
Class II · Moderate risk
Clomiphene Citrate USP Active Pharmaceutical Ingredient
cGMP deviations
Class II · Moderate risk
PReye Vitamin See Antioxidant Preservative Free Eye Drops
Lack of Assurance of Sterility
Class II · Moderate risk
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride
Subpotent Drug
Class II · Moderate risk
VistaPharm
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Class II · Moderate risk
VistaPharm
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Class II · Moderate risk
VistaPharm
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Class II · Moderate risk
VistaPharm
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Class II · Moderate risk
Duloxetine DR Capsules
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Class II · Moderate risk
Lidocaine HCl Injection USP
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL Citrate
Subpotent Drug
Class II · Moderate risk
Estradiol Gel
Defective Container; packets were found to be either empty or partially full.
Class II · Moderate risk
Gas-X
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Class II · Moderate risk
cimzia (certolizumab pegol)
Lack of Assurance of Sterility
Class II · Moderate risk
Amlodipine and Olmesartan Medoxomil Tablets
Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Class II · Moderate risk
Vitamin B-Complex
Presence of a Foreign Substance; black particles observed in liquid
Class II · Moderate risk
Atomoxetine Capsules HCL
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Class II · Moderate risk
Erythromycin Tablets
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit