Zep, Alcohol Sanitizer Spray
Microbial contamination of sterile products
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,535 recalls, newest first.
Microbial contamination of sterile products
Defective container:may contain bottles with incomplete seals
Defective container:may contain bottles with incomplete seals
Defective container:may contain bottles with incomplete seals
Defective container:may contain bottles with incomplete seals
Defective container:may contain bottles with incomplete seals
Defective container:may contain bottles with incomplete seals
Defective container:may contain bottles with incomplete seals
cGMP deviations
Lack of Assurance of Sterility
Subpotent Drug
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Lack of Assurance of Sterility
Subpotent Drug
Defective Container; packets were found to be either empty or partially full.
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Lack of Assurance of Sterility
Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Presence of a Foreign Substance; black particles observed in liquid
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit