The US Food and Drug Administration (FDA) announces that Apotex Corp. is voluntarily, on a precautionary basis, recalling Ranitidine Tablets 75mg and 150mg (all pack sizes and formats) to the retail level. Apotex has learned from the FDA and other global regulators that some ranitidine medicines including brand and generic formulations of ranitidine regardless of the manufacturer, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. To date, Apotex has not received any reports of adverse events related to use of the product. The affected products are:
- Ranitidine tablets, USP 150mg-acid reducer (Rite Aid)
- Ranitidine tablets, USP 150mg-acid reducer (Walmart)
- Wal-Zan® 150 RANITIDINE TABLETS, USP 150 mg / ACID REDUCER (WALGREENS)
- Wal-Zan® 75 RANITIDINE TABLETS, USP 75 mg / ACID REDUCER (WALGREENS)
- Cool mint Ranitidine tablets, USP 150 mg - acid reducer (Rite Aid)
NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-voluntary-nationwide-recall-ranitidine-tablets-75mg-and-150mg-all-pack-sizes-and
In Hong Kong, Apo-Ranitidine Tab 150mg (HK-42273) and Apo-Ranitidine Tab 300mg (HK-41873) are pharmaceutical products registered by Hind Wing Co Ltd.
Currently, there are 67 registered pharmaceutical products containing ranitidine in Hong Kong. These products in the forms of oral preparations and injections are controlled as over-the-counter medicines and prescription-only medicines respectively. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to ranitidine.
Related news on the detection of NDMA in ranitidine products was previously issued by European Medicines Agency, the United States Food and Drug Administration, Health Canada, Singapore Health Sciences Authority (HSA), Australia Therapeutic Goods Administration, and Taiwan Food and Drug Administration (TFDA), and was posted on the Drug Office website since 16 Sep 2019, with the latest update posted on 25 Sep 2019. Letters to inform local healthcare professionals were issued by the DH on 18 Sep 2019. The DH has contacted the relevant overseas drug regulatory authorities for further information regarding the detection of NDMA in ranitidine products, and continues to remain vigilant on the update findings and investigation result announced by the authorities.
In relation to the TFDA announcement on the suspension of sale of ranitidine, there were six brands of the products registered in Hong Kong. Of the six brands, the sale of two brands have already been suspended and products for two other brands were not available for sale in Hong Kong. As for the HSA announcement on the recall of 8 ranitidine brands, there were five brands registered in Hong Kong. Of the five brands, the sale of one brand has already been suspended and products for two other brands were not available for sale.
On 24 Sep 2019, the DH endorsed a licensed drug wholesaler, GlaxoSmithKline Ltd, to recall all products of the brand Zantac (ranitidine) from the Hong Kong market as a precautionary measure due to the presence of NDMA in the products. On 25 Sep 2019, the DH endorsed another two licensed drug wholesalers, Hind Wing Co Ltd and Top Harvest Pharmaceuticals Co Ltd, to recall all products of the brand Apo-Ranitidine tablets and Zantidon tablets 150mg (ranitidine) respectively from the Hong Kong market as a precautionary measure due to the potential presence of NDMA. Both Zantac and Apo-Ranitidine were related to the TFDA and the HSA announcements, and Apo-Ranitidine is also related to the above FDA announcement.
The DH has been contacting the certificate holders of all registered ranitidine products for follow up on the local impact of the issue; and to provide evidence that NDMA in the products are beneath the acceptable limit. The DH shall keep vigilant on the development of the issue and any safety update of the drug issued by overseas drug regulatory authorities for consideration of any action deemed necessary.
Patients who are taking ranitidine-containing products should not stop taking the medicines, but should seek advice from their healthcare professionals for proper arrangement, e.g. use of alternative medicines with similar uses.
Ends/Thursday, Sep 26, 2019
Issued at HKT 16:00
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