The United States Food and Drug Administration (FDA) announces that Sandoz Inc. is voluntarily recalling all quantities and lots within expiry of Ranitidine Hydrochloride Capsules to the consumer level because of confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA in batches of Sandoz Ranitidine Hydrochloride Capsules. To date, Sandoz has not received any reports of adverse events related to use of the product as part of this recall.
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. Ranitidine Hydrochloride Capsules is an oral product, indicated for the treatment of duodenal ulcer, benign gastric ulcer, reflux esophagitis, post-operative peptic ulcer, Zollinger-Ellison Syndrome, and other conditions where reduction of gastric secretion and acid output is desirable.
The affected Sandoz Ranitidine Hydrochloride Capsules below were distributed nationwide to wholesalers in the United States:
- RANITIDINE 150mg Capsules 500 count (Lot Numbers: HD1862, HP9438, HP9439 and HP9440)
- RANITIDINE 150mg Capsules 60 count (Lot Numbers: HC9266. HD1865, HP9441, JK7994 and JK8659)
- RANITIDINE 300mg Capsules 30 count (Lot Numbers: HD8625, HD9275, HU2207, HX6676 and HX6677)
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-voluntary-recall-ranitidine-hydrochloride-capsules-150mg-and-300mg-due-elevated
In Hong Kong, the above affected products are not registered pharmaceutical products.
In Hong Kong, there are 67 registered pharmaceutical products containing ranitidine. 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 and the latest update was 21 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 presence of NDMA. Both Zantac and Apo-Ranitidine were related to the TFDA and the HSA announcements.
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/ Wednesday, September 25, 2019
Issued at HKT 19:45
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