Prescription Drugs

Lack of assurance of sterility:

Lack of assurance of sterility:

Lack of assurance of sterility:

Lack of assurance of sterility:

Lack of assurance of sterility:

Lack of assurance of sterility:

Lack of assurance of sterility:

Subpotent: Failing Test Results for Epinephrine

Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).

Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.

Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.

Failed dissolution specifications - results obtained were below spec average.

Subpotent: Out of Specification result observed for low assay

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

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

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.