Drugs Recalls

Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.

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.

Chemical contamination: Presence of benzene

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.

Chemical contamination: Presence of benzene

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.