Prescription Drugs

Lack of Assurance of Sterility

Defective Delivery System: Missing or duplicated needles within the injection kit

cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.

Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil

Presence of Foreign Tablets/Capsules

Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.

CGMP Deviations: product found to contain lead.

Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution

Failed Impurities/Degradation Specifications

Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil.

Failed Disintegration Specifications: above the time expected.

Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules

Presence of Foreign Substance

Subpotent Drug

Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

Presence of Particulate Matter.

Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.

Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.