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Medication Safety Alerts

Losartan potassium 50 mg tablets manufactured by Torrent Pharmaceuticals LTD (repackaged by Legacy Pharmaceutical Packaging) - Voluntary Recall Expanded

April 24, 2019

On March 15, 2019, the United States Food and Drug Administration (FDA) issued a notice regarding a voluntary recall of Losartan potassium 50 mg tablets manufactured by Torrent Pharmaceuticals LTD that was repackaged by Legacy Pharmaceutical Packaging. On April 24, 2019, the recall was expanded to include one additional lot number that was not part of the previous recall of this product. This recall was issued because an unexpected impurity was found in these products that may cause a potential health hazard or safety risk to plan members who may be using product affected by this recall.

A complete list of the affected product and lot numbers is provided here:

If your product was dispensed in the manufacturer’s bottle, please check the repackaged lot number. The repackaged lot number is on the manufacturer’s label. If your product is not from one of these affected repackaged lots, it is not affected by this recall. If your product is from one of these affected repackaged lots or if your product was dispensed in a pharmacy’s bottle, please contact the pharmacy that filled your prescription for more information including return instructions.

Please note: The FDA recommends that patients who are on Losartan Potassium tablets should continue taking their medicine until they receive replacement product or a different medicine to treat their condition, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Please call your doctor right away for advice if you may be using affected product. Your doctor is familiar with your medical history and can suggest the best treatment option for you. If you need a prescription for a different medicine, please contact your doctor.

CVS Caremark Response:

Please note: CVS Caremark Mail Service Pharmacy does not carry Losartan Potassium 50 mg tablets repackaged by Legacy Pharmaceutical Packaging.

If you are currently taking Losartan Potassium 50 mg tablets and have questions regarding this recall, please call your doctor or call Inmar toll-free at 1-877-538-8443, Monday through Friday, 9 am to 5 pm (ET). You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line toll-free at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit www.fda.gov.

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