Alembic Pharmaceuticals is recalling 1 lot of Telmisartan Tablets 20mg due to a complaint related to incorrect product strength on the label. The Company received a report stating that a 30-count bottle labelled as the 20mg strength incorrectly contained 40mg strength tablets.
Telmisartan, an angiotensin II receptor blocker, is indicated for the treatment of hypertension. To date, Alembic has not received any adverse event reports related to the recall. However, patients who receive double the dose of telmisartan for a prolonged period of time may be at risk of experiencing hypotension, worsening renal function, and elevated potassium levels, which can be life-threatening.
The recalled product is packaged in a bottle containing 30 tablets with lot number 1905005661 and an expiration date of March 2022. Oval shaped tablets debossed with L203 on one side indicate the wrong tablet has been included in the bottle (40mg strength). The 20mg tablets should be white to off-white round shaped and debossed with L202 on one side.
Alembic is notifying its distributors and retailers about the issue and is arranging for return of the recalled lot.
For more information visit fda.gov.
Alembic Pharmaceuticals Limited issues voluntary nationwide recall of Telmisartan Tablets, USP, 20 mg due to label mix-up. [press release]. Silver Spring, MD: US Food and Drug Administration; March 24, 2021.