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Medicine recalls
 
Canada: Pharmascience Inc. recalls 30 lots of 150 mg over-the-counter ranitidine packaged in blister packs
 
Health Canada announces that Pharmascience Inc. is recalling 30 lots of over-the-counter ranitidine drugs (150 mg tablets), packaged in blister packs, after tests found N-nitrosodimethylamine (NDMA), a nitrosamine impurity, above the acceptable level in some lots. The products are sold under various private labels. For details of the affected products, please refer to the website in Health Canada.

Please refer to the following website in Health Canada for details: http://recalls-rappels.canada.ca/en/alert-recall/ranitidine-products-recalled-because-nitrosamine-impurity

In Hong Kong, the above products are not registered pharmaceutical products.

Currently, there are 37 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 various overseas drug regulatory authorities, and was posted on the Drug Office website since 16 Sep 2019, with the latest update posted on 4 Dec 2021. Letters to inform local healthcare professionals were issued by the DH on 18 Sep 2019 and 2 Apr 2020.

The following ranitidine products were affected and recalled from the Hong Kong market: HK-42792, HK-42793, HK-30459, HK-42045, HK-42273, HK-41873, HK-64329, HK-53143, HK-65103, HK-62210, HK-61752, HK-56826, HK-57473, HK-56824, HK-56823, HK-56825, HK-57472, HK-43456, HK-50378, HK-60085, HK-64041, HK-61083, HK-53488, HK-59353, HK-59429 and HK-36650 on 24 Sep 2019, 25 Sep 2019, 27 Sep 2019, 30 Sep 2019, 11 Oct 2019, 1 Nov 2019, 7 Nov 2019, 12 Nov 2019, 27 Nov 2019 and 27 Aug 2020.

On 16 Jun 2020, the Registration Committee of the Pharmacy and Poisons Board discussed the matter and decided to keep vigilant on any safety update issued by overseas drug regulatory authorities for consideration of any action deemed necessary.

Patients who are taking ranitidine-containing products should seek advice from their healthcare professionals for proper arrangement, e.g. use of alternative medicines with similar uses.

Ends/Saturday, Mar 12, 2022
Issued at HKT 12:00
 
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