PRA number
2016/15285
Published date
Product description
Thiamine hydrochloride is a type of vitamin B and is used to treat vitamin deficiency. Clopidogrel is used to prevent blood clots in patients with certain heart and blood vessel disorders.
Reasons the product is recalled
The recall is due to the potential that some bottles may contain at least one Plavix/Iscover (clopidogrel 75 mg) tablet.
The hazards to consumers
If a clopidogrel tablet is accidentally consumed there is a low risk of increased bleeding and/or other adverse interactions in patients who are already prescribed with clopidogrel or other medicines that affect blood clotting.
What consumers should do
If you or someone you care for takes Betamin 100 mg tablets, check the product packaging for the batch number and expiry date.
If you have Betamin tablets from batch number 124E001 (expiry 02/18) do not take them. Return them to the place of purchase for a refund or a replacement.
If you have any questions or concerns about this issue, speak to your health professional or call Sanofi on 1800 818 806.
If you have Betamin tablets from batch number 124E001 (expiry 02/18) do not take them. Return them to the place of purchase for a refund or a replacement.
If you have any questions or concerns about this issue, speak to your health professional or call Sanofi on 1800 818 806.
Supplier
Sanofi-Aventis Australia Pty Ltd
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.