Medicine recalls
|
| |
| The United States: Alembic Pharmaceuticals Limited issues voluntary nationwide recall of Telmisartan Tablets, USP, 20 mg due to label mix-up |
| |
The US Food and Drug Administration (FDA) announces that Alembic Pharmaceuticals, Inc is voluntarily recalling one lot of Telmisartan Tablets, USP, 20 mg, packaged in 30-count bottles, Lot No. 1905005661 to the consumer level. The product is being recalled due to a market complaint received which stated that one bottle labelled as 30-count Telmisartan Tablets, USP, 20 mg incorrectly contained 30 tablets of Telmisartan Tablets, USP, 40mg.
Patients who could be on a doubled dose of telmisartan for a prolonged period of time, could experience low blood pressure, worsening of kidney function, or an elevation of potassium which can be life-threatening. To date, Alembic Pharmaceuticals Limited has not received any reports of adverse events related to this recall.
The wrong product can be identified by checking the shape and embossing details on the tablets, i.e. Telmisartan Tablets, USP, 20 mg bottles may incorrectly contain oval shaped white to off-white tablets debossed with L203 on one side instead of correct product, i.e. round shaped white to off-white tablets debossed with L 202 on one side.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/alembic-pharmaceuticals-limited-issues-voluntary-nationwide-recall-telmisartan-tablets-usp-20-mg-due
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Thursday, Mar 25, 2021
Issued at HKT 17:00
|
| |
