Prescription Drugs

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification

Presence of Particulate Matter.

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) - Sildenafil.

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.