Prescription and over-the-counter medications
SUN PHARMACEUTICAL INDUSTRIES
Subpotent: Out of Specification result observed for low assay
AMMAN PHARMACEUTICAL INDUSTRIES
Lack of Assurance of Sterility
AMMAN PHARMACEUTICAL INDUSTRIES
Lack of Assurance of Sterility
Hua Da Trading, Inc.
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil, an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
Failed Impurities/Degradation Specifications
Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
Failed dissolution specifications: below specification results at stability 12-month
Marlex Pharmaceuticals
Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.
Marlex Pharmaceuticals
Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.
Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
Central Admixture Pharmacy Services
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Central Admixture Pharmacy Services
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Central Admixture Pharmacy Services
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Central Admixture Pharmacy Services
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Central Admixture Pharmacy Services
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Central Admixture Pharmacy Services
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles