WASHINGTON, D.C. – The U.S. Food and Drug Administration issued a recall notice stating that Alembic Pharmaceuticals Limited has begun a nationwide recall of its Telmisartan Tablets, USP, 20 mg because of a labeling error. Telmisartan is used to treat hypertension and helps to lower a patient’s blood pressure. The Telmisartan tablet recall states that one lot of 30-count 20 mg Telmisartan tablets contain 40 mg Telmisartan tablets. Patients prescribed 20 mg Telmisartan are at risk for taking double the prescribed dosage because of the labeling error. When a patient takes a higher dose of Telmisartan than prescribed and over a long time could experience dangerous side effects such as dangerously low blood pressure, damage to the kidneys, or elevated levels of potassium which could be fatal.
Alembic Pharmaceuticals, Inc, based in Bridgewater, New Jersey, is recalling one lot of its 20 mg Telmisartan tablets packaged in 30-count bottles. The affected Telmisartan has an expiration date of March 2022, a Lot Number of 1905005661, and an NDC Number 62332-087-30. The affected tablets are identifiable by the shape of the tablet and the embossing details on the tablets. The affected Telmisartan tablets may incorrectly contain white to off-white, oval-shaped tablets debossed with “L 203.” The correct product is a round-shaped, white to off-white tablet with a debossed with “L 202” on one side.
The recalled Telmisartan Tablets, USP, 20mg, with Lot Number 1905005661 was distributed to wholesalers, retailers, and pharmacies nationwide. Alembic Pharmaceuticals Limited has been advising its retailers and distributors about the recall by letter. Alembic Pharmaceuticals Limited is arranging for the return of the recalled lot. Consumers who have the affected Telmisartan 20 mg tablets are urged not to discontinue use until talking with their healthcare professional or pharmacist about a replacement and prior to returning the medication to the place of purchase for a refund.
Consumers who have questions regarding the recall may contact Alembic Pharmaceuticals Inc through their website alembicusa.com or their website’s contact information. Patients should also contact their healthcare provider if they are experiencing any problems related to using the medication.
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