Health Canada announces that Dominion Pharmacal, Laboratoire Riva Inc., Pharmascience Inc. and Vita Health Inc. are recalling all lots of their prescription and over-the-counter ranitidine products from the Canadian market as a precautionary measure. The affected products are:
Dominion Pharmacal:
- Maximum Strength Acid Reducer Without Prescription (ranitidine) sold under the brand name Personnelle 150mg
Laboratoire Riva Inc.:
- Riva-Ranitidine 150 150mg
- Riva-Ranitidine 300 300mg
- Acid Reducer (ranitidine) sold under the brand names Biomedic, Circle K and Option+ 75mg
Pharmascience Inc.:
- PMS-Ranitidine 150 mg
- PMS-Ranitidine 300 mg
- Acid Reducer (ranitidine) sold under the brand names Atoma, Biomedic, Compliments, Exact, Life Brand, London Drugs, Option+, Personnelle, Pharmasave, Preferred Pharmacy, Rexall and Selection 75mg
- Maximum Strength Acid Reducer Without Prescription (ranitidine) sold under the brand names Atoma, Biomedic, Compliments, Co-op Care+, Equate, Exact, Health One, Kirkland Signature, London Drugs, Option+, Personnelle, Pharmasave, Rexall and Selection 150mg
- Acid Reducer (ranitidine) sold under the brand names Exact and Life Brand 150mg
Vita Health Products Inc.:
- Acid Reducer (ranitidine) sold under the brand names Equate, iPharma, Stanley and Western Family 75mg
- Maximum Strength Acid Reducer (ranitidine) sold under the brand names Equate, iPharma and Western Family 150mg
Please refer to the following website in Health Canada for details:
http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../71029a-eng.php
In Hong Kong, the above products are not registered pharmaceutical products.
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 26 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/Monday, Oct 28, 2019
Issued at HKT 16:00
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