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Type of Product Medicine
TGA Recall Reference RC-2019-RN-01455-1
Product Name/Description Apotex Ranitidine Tablets

- APO-Ranitidine 150mg & 300mg tablets
- CHEMMART Ranitidine 150mg & 300mg tablets
- TERRY WHITE CHEMISTS Ranitidine 150mg & 300mg tablets
- APOHEALTH Ranitidine Acid and Heartburn 150mg & 300mg tablets

All Batches within expiry

ARTGs: 121979, 122014, 121978, 254413, 143188, 121975, 254412, 121976 & 122013
Recall Action Level Retail
Recall Action Classification Class II
Recall Action Commencement Date 30/09/2019
Responsible Entity Apotex Pty Ltd
Reason/Issue Apotex Australia were made aware that trace amounts of N-Nitrosodimethylamine (NDMA) may be present, which is consistent with several other products globally.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. It is also a known environmental contaminant found in water and foods, including meats, dairy products and vegetables.

The actual health risks depend on dose and will vary from person to person. While long term exposure, over years, can increase an individual’s risk of developing cancer, the risks from short-term are expected to be extremely low.
Recall Action Recall
Recall Action Instructions Retailers: Apotex is advising customers to inspect stock on hand for the affected Ranitidine products and quarantine all impacted product to prevent further use. Contact the Wholesaler to arrange for the return of the stock and a suitable refund will be applied Wholesalers: Apotex is advising customers to inspect stock on hand for the affected Ranitidine products and quarantine all impacted product to prevent further use. Following receipt of a completed Facsimile Reply Form (supplied to impacted customers), Apotex will arrange for stock to be recovered and a credit note issued.
Contact Information 1800 276 839 - Apotex Customer Service