💊 Drugs • 12,141 recalls
SUN PHARMACEUTICAL INDUSTRIES
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Novartis Pharmaceuticals
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules
Lack of Assurance of Sterility
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
Carolina Infusion
Lack of Assurance of Sterility
Carolina Infusion
Lack of Assurance of Sterility
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Carolina Infusion
Lack of Assurance of Sterility
Microbial contamination of non-sterile products.
Carolina Infusion
Lack of Assurance of Sterility
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Carolina Infusion
Lack of Assurance of Sterility
Presence of particulate matter
Microbial contamination of non-sterile products.
Lack of Assurance of Sterility
Carolina Infusion
Lack of Assurance of Sterility