Prescription and over-the-counter medications
Safecor Health
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Safecor Health
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
The Harvard Drug Group LLC
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.
Subpotent Drug
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
VIONA PHARMACEUTICALS
Crystallization
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Dr. Reddy's Laboratories
Failed Impurities/Degradation Specification
Labeling: Missing Label
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Staska Pharmaceuticals
Presence of Particulate Matter: Presence of glass particulates.
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Dr. Reddy's Laboratories
Failed Impurities/Degradation Specification
BLI International
Superpotent Drug: Stability failure for assay at 6 months test time-point.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Dr. Reddy's Laboratories
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.