| 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 |
|
| 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.
This action has been closed out on 14/01/2022 |
| Contact Information |
1800 276 839 - Apotex Customer Service |