Prescription Drugs

Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.

CGMP Deviations: products were stored outside the drug label specifications.

CGMP Deviations: products were stored outside the drug label specifications.

Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.

Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.

Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets

Labeling: Label Error on Declared Strength

Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .

Lack of Assurance of Sterility

Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.

Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .

Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time

Defective Container: Tube split from side seam

Failed Dissolution Specifications: below specification limits for dissolution.

Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil.

Failed Dissolution Specifications: below specification limits for dissolution.

Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.

FAILED DISSOLUTION SPECIFICATIONS

Superpotent Drug: Out of specification assay result was obtained during stability testing.

Labeling: Missing label: Label missing from some prefilled pens.