Recall underway


recall regulatory

Recall notice issued for several Zantac brands following contamination fear

The TGA is advising consumers and health professionals that several ranitidine-containing products have been removed from the Australian market due to contamination with an impurity called N‑nitrosodimethylamine (NDMA).

“Ranitidine tablets and oral liquids are now in short supply as a number of commonly-used brands have been recalled from pharmacies, hospitals, wholesalers, and other retail outlets, such as supermarkets and online stores,” the TGA has advised in an update on its website.

“Additional brands may be recalled as TGA continues testing and discussions with companies that supply ranitidine,” it says.

In its notice on the System for Australian Recall Actions (from 1 October), Aspen Pharmacare said it had “initiated a recall following the confirmation of trace amounts of N-nitrosodimethylamine (NDMA) as being present in Zantac Ranitidine batches”.

“This is a global anomaly, that affects more than one type and brand of medicine.”

Aspen is advising pharmacies to: “Inspect stock on hand and quarantine all impacted product to prevent further use, and contact your Wholesaler to arrange for the return of the stock and a suitable refund will be applied.”

NDMA is classified as a probable human carcinogen based on results from laboratory tests. It is also a known environmental contaminant found in water and foods, including meats, dairy products, and vegetables.

Pharmacists who are providing advice to patients accessing ranitidine over the counter should discuss treatment options and review whether ongoing pharmacotherapy is appropriate, the TGA advises.

“Health professionals can reassure patients that the additional risk posed by NDMA from ranitidine at the levels identified to date is very low. However, for patients who are currently taking ranitidine these risks may outweigh the clinical benefits.”

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