| Type of Product |
Medicine |
| TGA Recall Reference |
RC-2019-RN-01311-1 |
| Product Name/Description |
Sandoz Ranitidine
Mylanta Ranitidine 300mg 24Hour Action Tablet 14’s Blister ARTG 116268
RANITIDINE Sandoz 300mg Tablet 30's ARTG 70356
RANITIDINE Sandoz 150mg Tablet 60's Blister pack ARTG 70325
RANITIDINE GH 300mg Tablet 30’s Blister ARTG 219142
RANITIDINE GH 150mg Tablet 60’s Blister ARTG 219141
RANITAL FORTE ranitidine 300mg film-coated tablet blister pack ARTG 117184
RANITAL 150mg TABLETS ranitidine 150mg blister pack ARTG 75206 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/09/2019 |
| Responsible Entity |
|
| Reason/Issue |
Sandoz Australia were made aware that in two batches of their ranitidine product tested by Swissmedic – NDMA was identified.
These particular batches have not been supplied to the Australian market, however, further testing revealed Australian supplied product is affected.
As a precautionary measure, Sandoz is undertaking a Retail Level Recall whilst a full investigation is undertaken and the necessary corrective actions can be put in place. |
| Recall Action |
Recall |
| Recall Action Instructions |
Sandoz is requesting customers:
1. Inspect all relevant stock on hand;
2. Quarantine any stock you may have of the affected products; and
3. If you have supplied or transferred any potentially affected product to another facility or organisation, let that facility know of this recall immediately by providing them a copy of the customer letter. |
| Contact Information |
02 8874 2345 - Sandoz |