Drug Recall

Further to DrugAlert Vol 504, HPS Pharmacies wish to advise that Apotex, in consultation with the Therapeutic Goods Administration (TGA), has also initiated a drug recall of ranitidine products.

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

Product Strength ARTG

Zantac® Oral Liquid

150mg/10mL 35188

Zantac® Tablets

150mg 53324

Zantac® Tablets

300mg 53323

Zantac® Effervescent Tablets

150mg 45993

Zantac® Injection Ampoules

50mg/2mL 12536

Zantac® Double Strength Tablets (OTC)

300mg 95076

Zantac® Tablets (OTC)

150mg 71786


150mg 122013


300mg 122014

Chemmart Ranitidine

150mg 121976

Chemmart Ranitidine

300mg 121979

Terry White Chemists Ranitidine

150mg 121975

Terry White Chemists Ranitidine

300mg 121978

ApoHealth Ranitidine Acid and Heartburn

150mg 254412

ApoHealth Ranitidine Acid and Heartburn

300mg 254413

Mylanta® Ranitidine 24 Hour Action

300mg 116268

Ranitidine Sandoz

150mg 70325

Ranitidine Sandoz

300mg 70356

Ranitidine GH

150mg 219141

Ranitidine GH

300mg 219142

Ranital® Forte

300mg 117184


150mg 75206

The TGA has suspended the supply of all other ranitidine products to Australian warehouses pending further investigation.

This recall has been initiated following confirmation of the presence of trace amounts of the impurity, N-nitrosodimethylamine (NDMA) in these products. 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.

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.

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.

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