Medicine recalls
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| Canada: Recall: Thiamiject Injection |
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Health Canada announces that Omega Laboratories Ltd. is recalling 6 lots of Thiamiject Injection (thiamine hydrochloride 100mg/ml) (lot number: 7K940, 7M997, 8G265, 8K328, 9A435A, 9A435B) from wholesalers, healthcare establishments and retailers because the assay is out of specification in the affected lots.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../71579r-eng.php
In Hong Kong, Thiamiject Injection 1000mg/10ml (HK-62703) is a pharmaceutical product registered by Sino-Asia Pharmaceutical Supplies Ltd (Sino-Asia), and is a prescription-only medicine.
On 8 Nov 2019, the Department of Health (DH) endorsed Sino-Asia to recall one lot of Thiamiject Injection (lot number: 7K940; manufacturing date: 2017-10-11) from the Hong Kong market. The DH received notification from Sino-Asia that the stability test of the above-mentioned product indicated that the content of active ingredient was less than the specifications at the end of the 36-month shelf-life. Therefore, the manufacturer decided to shorten the product’s shelf-life from 36 months to 24 months. The above-mentioned lot was manufactured in 2017 and therefore has passed the new shelf-life. As a precautionary measure, Sino-Asia is recalling the affected lot from the market. The DH will closely monitor the recall.
As confirmed with Sino-Asia, the following lots have also been imported into Hong Kong:
- lot number: 7M997; manufacturing date: 2017-12-12
- lot number: 8G265; manufacturing date: 2018-07-30
- lot number: 9A435A; manufacturing date: 2019-01-04
The DH has contacted Health Canada for further information regarding the recall, and continues to follow-up with Sino-Asia on the matter for consideration of any action deemed necessary.
The other 2 lots recalled in Canada have not been imported into Hong Kong.
Ends/Wednesday, Nov 13, 2019
Issued at HKT 16:00
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