Prescription Drugs

Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.

Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.

Presence of particulate matter - Glass like particles.

Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.

Out of specification for dissolution.

Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.

Presence of particulate matter - Glass like particles.

Presence of particulate matter - Glass like particles.

Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.

Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.

Presence of Particulate Matter: Hair was found in a prefilled syringe

Presence of Particulate Matter: Hair was found in a prefilled syringe

Presence of particulate matter: potential presence of metal particulates in the product.

Presence of particulate matter: potential presence of metal particulates in the product.

Failed stability specifications: Out of specification for hardness test

Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.

Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.

Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.

Defective container - seal not adhering to bottles

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.