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 agreedacceptable 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;
Each of these named products tested at or below 0.2 ppm NDMA contamination, and remain on sale.
Go to tga.gov.au for more information
Source: Pharmacydaily.com.au, Thu 24 Oct 2019