676 recalls · Class II, newest first
Reason Presence of particulate matter: potential presence of metal particulates in the product.
Reason Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
Reason cGMP Deviations
Reason cGMP Deviations
Reason Presence of Foreign Tablets/Capsules
Reason CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Reason CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Reason Incorrect Product Formulation
Reason Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and…
Reason CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Reason CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Reason CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Reason Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Reason Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis
Reason Defective container - seal not adhering to bottles
Reason Defective container: cracked/broken cartridges
Reason Defective container: cracked/broken cartridges
Reason Defective container: cracked/broken cartridges
Reason Defective container: cracked/broken cartridges
Reason Defective container: cracked/broken cartridges
Reason Defective container: cracked/broken cartridges
Reason Defective container: cracked/broken cartridges
Reason cGMP deviations
Reason cGMP deviations
Reason cGMP deviations