Drug Recall

Further to DrugAlert Vol 505, HPS Pharmacies wish to advise that the Therapeutic Goods Administration (TGA) has initiated drug recalls of additional ranitidine products.

All batches of the following products are currently affected by a recall:

This recall has been initiated following confirmation of, or in some cases the potential presence of, trace amounts of the impurity, N-nitrosodimethylamine (NDMA). The TGA advises that consumers are not at immediate risk with the use of ranitidine products as the risks are associated with long-term exposure to the NDMA contaminant. Further information can be found on the TGA website.

The TGA has analysed sample batches of Ranitidine Sandoz^® 50mg/5mL concentrated injection. No NDMA was detected in these samples, therefore, there is no recall required for Ranitidine Sandoz^® ampoules. However, the TGA has suspended the supply of all ranitidine products to Australian warehouses pending further investigation.

Patients who have been prescribed ranitidine are advised to continue taking their medication until they have spoken with their doctor about appropriate alternatives. Healthcare professionals can consult the National Prescribing Service for advice regarding the management of gastro-oesophageal reflux disease and acid reflux during pregnancy.

Possible alternatives to ranitidine include:

• An alternate H₂ receptor antagonist;
• A proton pump inhibitor; and/or
• Diet and lifestyle modification.

Please inspect your stock and quarantine all affected products. If HPS Pharmacies provide imprest management services to your facility, an HPS representative will inspect all stock stored in the designated imprest areas at the earliest opportunity. All affected products will be quarantined for return to the supplier and HPS Pharmacies will arrange for replacement stock as soon as possible. An HPS Pharmacies staff member will contact senior medical and nursing staff if there is an immediate impact to your facility.

This notice replaces previous alerts regarding ranitidine recalls. Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact your pharmacist at HPS Pharmacies.