Ranitidine NDMA Contamination Update

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;

• 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.

Go to tga.gov.au for more information

Source: Pharmacydaily.com.au, Thu 24 Oct 2019