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Drug Safety Alerts
Losartan Potassium 50 mg tablets manufactured by Torrent Pharmaceuticals, LTD (repackageded by Legacy Pharmaceutical Packaging) - Consumer-level Recall Expanded
04/24/2019
On April 24, 2019, the United States Food and Drug Administration (FDA) issued a notice regarding an extended consumer-level recall of Losartan Potassium 50 mg tablets NDC # 68645-0494-54. This recall was prompted due to Torrent Pharmaceuticals, LTD issuing a voluntary nationwide recall of Losartan tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).
A complete list of the affected product and lot numbers is provided here:
Note: This recall was originally received on March 15, 2019 for three repackaged lots. This recall was expanded on April 24, 2019 to include one additional lot.
NMBA is a potential human carcinogen. To date, Legacy Pharmaceutical Packaging has not received any reports of adverse events related to this recall.
Losartan Potassium tablet, USP is a prescription medication used to treat high blood pressure and congestive heart failure and is packaged in 30 count bottles.
Patients who are on Losartan potassium tablets should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.
CVS Caremark Response: CVS Caremark Mail Service Pharmacy does not carry Losartan Potassium 50 mg tablets repackaged by Legacy Pharmaceutical Packaging.
For more information about the recall please 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 at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov.