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CGMP Deviations
CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
CGMP Deviations; potential temperature excursions due to transit delays
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
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.
cGMP Deviations
Presence of Particulate Matter
Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of the Dexonto 0.4% are labeled incorrectly with a BUD of 12/25/2025.
Lack of Assurance of Sterility
Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil.