The Therapeutic Goods Administration (TGA) has issued an update on the levels of N-nitrosodimethylamine (NDMA) contamination in ranitidine samples tested.
The initial alert from the TGA relating to NDMA contamination was issued in Sep (PD 20 Sep).
"NDMA belongs to a class of chemicals called nitrosamines and is classified as a probable human carcinogen," the TGA site states.
The internationally agreed acceptable limit for NDMA in the ranitidine active ingredient is set at 0.3 parts per million (ppm).
A total of 135 batch samples of ranitidine medicines have been tested by the TGA Laboratories, using a publicly available US Food and Drug Administration test method and resulting in a recall of all products testing at or above this limit.
The consequence is that all ranitidine products have been recalled and removed from pharmacy shelves except AUSRAN ranitidine 150mg tabs, AUSRAN ranitidine 300mg tabs, CHEMISTS' OWN RANITIDINE FORTE ranitidine 300mg tabs, CHEMISTS' OWN RANITIDINE 150mg tabs and RANITIDINE SANDOZ ranitidine 50mg/5mL concentrated injection ampoules.
Each of these named products tested at or below 0.2 ppm NDMA contamination, and remain on sale - tga.gov.au.
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