PReye Vitamin See Antioxidant Preservative Free Eye Drops
Lack of Assurance of Sterility
Every FDA drug recall whose status is still Ongoing: the firm is still removing product from the market, or the FDA has not yet closed the file. Some were opened years ago and never formally terminated, so check the initiation date as well as the status.
2,760 recalls, newest first.
Lack of Assurance of Sterility
Subpotent Drug
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Failed Stability Specifications
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
Failed Impurities/Degradations Specifications
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Presence of Particulate matter: Particulate matter identified as glass.
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
Failed Impurities/Degradation Specifications
Presence of a Foreign Substance; black particles observed in liquid
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
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
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit