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cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Lack of Assurance of Sterility
cGMP deviations
OOS results reported for the Dissolution (by UV) test.
Defective delivery system
Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Failed Dissolution Specifications
Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
Failed Impurities/Degradation Specifications
Presence of Particulate Matter: Glass particles were found in pellet vials.