STATEN ISLAND, N.Y. — A blood pressure medication is being recalled because the tablets inside the bottle don’t match what the label states, according to a notice from the U.S. Food and Drug Administration (FDA).
Alembic Pharmaceuticals, Inc. is recalling one lot of Telmisartan Tablets, USP, 20 mg, packaged in 30-count bottles with a lot number of 1905005661. This product is used to treat hypertension to lower blood pressure.
It’s being recalled due to a market complaint received that stated one bottle was labeled as 30-count Telmisartan Tablets, USP, 20 mg, but incorrectly contained 30 tablets of Telmisartan Tablets, USP, 40 mg. They were distributed nationwide to wholesalers, retailer, and pharmacies. It’s packaged in a bottle of 30 tablets with an NDC Number 62332-087-30.
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 hasn’t 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, which may incorrectly contain oval-shaped white to off-white tablets debossed with L203 on one side, instead of the correct product, which contains round-shaped white to off-white tablets debossed with L 202 on one side.
The company is notifying distributors and retailers through letters and arranging for return of the recalled lot. Consumers with this medication shouldn’t discontinue use until speaking with their pharmacist or healthcare professional for a replacement before returning to place of purchase.
Consumers with questions regarding this recall can contact Alembic Pharmaceuticals Inc. by phone at 1-908-552-5839 or email david.cobb@alembicusa.com. 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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March 29, 2021 at 01:20AM
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Blood pressure medication recalled for label mix-up - silive.com
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