Drug Safety Alerts

Legacy Pharmaceutical Packaging Losartan potassium 50 mg Tablets - Consumer-level Recall

03/15/2019

On March 15, 2019, the United States Food and Drug Administration (FDA) issued a notice regarding a consumer-level recall of 3 repackaged lots 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).

NMBA is a potential human carcinogen. To date, Legacy 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 50 mg 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.

The recall affects repackaged lot numbers 180190 exp. 10/2020, 180191 exp. 10/2020, and 181597 exp. 02/2021.

CVS Caremark Response: The repackaged product by Legacy Pharmaceutical Packaging is not carried by the CVS Caremark Mail Service Pharmacies.

For more information about this recall, please call Inmar Pharmaceuticals Services toll free at 1‑877‑538‑8443. 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 https://www.fda.gov.