Prescription and over-the-counter medications
Rubicon Research Private Limited
Discoloration
LABELING: LABEL MIX-UP.
Microbial contamination of non-sterile Products -
Lack of Assurance of Sterility
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Dr. Reddy's Laboratories
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Preferred Pharmaceuticals
Failed Impurities/Degradation Specifications - at 18-month Stability testing
Failed Dissolution Specifications: below specification results
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Dr. Reddy's Laboratories
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Dr. Reddy's Laboratories
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Teva Pharmaceuticals USA
Superpotent Drug
CGMP Deviations: sterile water not used for production
Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.