TOPIC: Telmisartan Tablets USP, 20 mg by Alembic Pharmaceuticals: Recall – Due to Label Mix-Up
AUDIENCE: Patient, Health Professional, Risk Manager, Pharmacy
ISSUE: Alembic Pharmaceuticals Limited is recalling one lot of Telmisartan Tablets USP, 20 mg, packaged in 30-count bottles, Lot No. 1905005661. 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.
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.
To date, Alembic Pharmaceuticals Limited has not received any reports of adverse events related to this recall.
For more information about this recall, click on the red button “Read Recall” below.
BACKGROUND: The product is used for the treatment of hypertension i.e. to lower blood pressure.
RECOMMENDATIONS:
- Consumers that may have Telmisartan Tablets USP, 20 mg which is being recalled should not discontinue use until speaking with their pharmacist or healthcare professional for a replacement before returning to place of purchase.
- Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
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