Drug Recall and Product Hold

Further to DrugAlert Vol 499, HPS Pharmacies wish to advise that the Therapeutic Goods Administration (TGA) has initiated a drug recall for the following ranitidine products.

Brand Formulation ARTG
Mylanta® Ranitidine 24 Hour Action 300mg tablets 116268
Ranitidine Sandoz 300mg tablets 70356
Ranitidine Sandoz 150mg tablets 70325
Ranitidine GH 300mg tablets 219142
Ranitidine GH 150mg tablets 219141
Ranital® Forte 300mg tablets 117184
Ranital® 150mg tablets 75206

This recall has been initiated following the identification of the impurity, N-nitrosodimethylamine (NDMA) in some Australian supplied products. NDMA is classified as a probable human carcinogen and can be found in low levels in a variety of foods, some drinking water, and air pollution. The recall is a precautionary measure while Sandoz Australia conducts a full investigation.

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.

In addition to the above recall, the TGA has announced that all sponsors of ranitidine are to suspend supply to pharmacy wholesalers and retailers. The TGA is allowing the continued supply and sale of existing stock at the wholesale and retail levels until current supplies are exhausted. The TGA will provide further information as it becomes available.

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.

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 Sandoz Australia on (02) 8874 2345 or your pharmacist at HPS Pharmacies.

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