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:

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
APO-Ranitidine Tablets 150mg 122013
APO-Ranitidine Tablets 300mg 122014
Chemmart Ranitidine Tablets 150mg 121976
Chemmart Ranitidine Tablets 300mg 121979
Terry White Chemists Ranitidine Tablets 150mg 121975
Terry White Chemists Ranitidine Tablets 300mg 121978
ApoHealth Ranitidine Acid and Heartburn Tablets 150mg 254412
ApoHealth Ranitidine Acid and Heartburn Tablets 300mg 254413
Mylanta® Ranitidine 24 Hour Action Tablets 300mg 116268
Ranitidine Sandoz Tablets 150mg 70325
Ranitidine Sandoz Tablets 300mg 70356
Ranitidine GH Tablets 150mg 219141
Ranitidine GH Tablets 300mg 219142
Ranital® Forte Tablets 300mg 117184
Ranital® Tablets 150mg 75206
Pharmacy Choice Acid & Heartburn Relief Tablets 150mg  192601
Pharmacy Choice Acid & Heartburn Relief Extra Strength Tablets 300mg 194056
Rani 2® Tablets 150mg 285696
Rani 2® Tablets 300mg 285693
Pharmacy Action Heartburn & Acid Indigestion Relief Tablets 150mg 191837
Pharmacy Action Heartburn & Acid Indigestion Relief Forte Tablets 300mg 191838
Pharmacy Care Heartburn Relief Tablets 150mg 219877
Pharmacy Care Heartburn Relief Extra Strength Tablets 300mg  219926
Amcal Heartburn Relief Tablets 150mg 219875
Amcal Heartburn Relief Extra Strength Tablets 300mg 219924

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.

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