藥 物 回 收
|
| |
| The United States: Lupin Pharmaceuticals, Inc. issues voluntarily nationwide recall of all Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets due to potential presence of N-nitrosoirbesartan impurity (English only) |
| |
The US Food and Drug Administration (FDA) announces that Lupin Pharmaceuticals Inc. is voluntarily recalling all batches of Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets to the consumer level. As part of Lupin’s ongoing assessment, analysis revealed that certain tested API batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan. Although Lupin has received no reports of illness that appear to relate to this issue, the company, out of an abundance of caution, is recalling all batches of Irbesartan Tablets USP 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg in the US.
Lupin discontinued the marketing of Irbesartan and Irbesartan and Hydrochlorothiazide Tablets in Jan 2021.
N-nitrosoirbesartan impurity is a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. From 8 Oct 2018 (the earliest date of shipment from the manufacturing site of any of the affected batches) to 30 Sep 2021, Lupin received 4 reports of illness from Irbesartan and no reports from Irbesartan and Hydrochlorothiazide.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntarily-nationwide-recall-all-irbesartan-tablets-and-irbesartan
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Friday, Oct 15, 2021
Issued at HKT 16:00
|
| |
