The US Food and Drug Administration (FDA) announces that Perrigo Company plc has initiated a voluntary, worldwide product recall to the retail customer level of ranitidine (all pack sizes) as a precautionary measure. The recall is being taken due to possible presence of a nitrosamine impurity called N-nitrosodimethylamine (NDMA).
After regulatory bodies announced that ranitidine may potentially contain NDMA, Perrigo promptly began testing of its externally sourced ranitidine API (active pharmaceutical ingredient) and ranitidine-based products. On 8 Oct 2019, Perrigo halted shipments of the product based upon preliminary results. Based on the totality of data gathered to date, Perrigo has made the decision to conduct this voluntary recall.
Perrigo will continue to communicate ongoing testing results with health authorities. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
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/perrigo-company-plc-issues-voluntary-worldwide-recall-ranitidine-due-possible-presence-impurity-n
In Hong Kong, there is no registered ranitidine-containing product manufactured by the above company.
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 N-nitrosodimethylamine (NDMA) in ranitidine products was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 16 Sep 2019, with the latest update posted on 21 Oct 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 for consideration of any action deemed necessary.
The DH has contacted 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 below the acceptable limit, and samples of ranitidine-containing products have been collected from the market for analysis. When any health risks are posed to the public, a press statement will be issued as soon as possible. The following are the main content of the press statements issued previously:
- On 24 Sep 2019, the DH endorsed a licensed drug wholesaler, GlaxoSmithKline Ltd, to recall all Zantac products (HK-42792, HK-42793, HK-30459, HK-42045) 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 licensed drug wholesalers Hind Wing Co Ltd and Top Harvest Pharmaceuticals Co Ltd to recall Apo-Ranitidine Tablets (HK-42273, HK-41873) and Zantidon Tablets 150mg (HK-64329) respectively.
- On 27 Sep 2019, the DH endorsed licensed drug manufacturer APT Pharma Limited and licensed drug wholesaler Eugenpharm International Limited to recall Amratidine Tablets 150mg (HK-53143) and Peptil H 150 Tablets 150mg (HK-65103) respectively.
- On 30 Sep 2019, the DH endorsed licensed drug wholesaler Vast Resources Pharmaceutical Limited to recall Weidos Tablets 150mg (HK-62210).
- On 11 Oct 2019, the DH endorsed licensed drug wholesaler Hind Wing Co Ltd to recall Epadoren Solution for Injection 50mg/2ml (HK-61752).
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, Oct 24, 2019
Issued at HKT 16:00
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