New Impurity Leads to Recall of One Additional Lot of Losartan Potassium 50 mg Tablets

Date: 05/20/19

Attention Members and Providers: MHS wants you to know about a recent drug recall.

On April 24, 2019 the U.S. Food and Drug Administration (FDA) announced that Legacy Pharmaceutical Packaging, LLC was recalling one additional lot of Losartan Potassium 50 mg tablets to the consumer level due to the identification of a new impurity, NMBA.

The FDA press release states the following:

Legacy Pharmaceutical Packaging, LLC is expanding its consumer-level recall of three repackaged lots of Losartan Potassium Tablets USP 50 mg to include one additional lot. 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, USP, is a prescription medication used to treat high blood pressure and congestive heart failure and is packaged in 30ct bottles. The affected Losartan Potassium 50 mg tablets include four repackaged lot numbers, three initial repackaged lots (180190, 180191, 181597, with expiration dates 10/2020, 10/2020, 02/2021) and one expanded repackaged lot (181598, with expiration date 2/2021). The identifying NDC # associated with Legacy’s recalled product is 68645-0494-54.

Losartan Potassium was distributed by pharmacies nationwide. Legacy Pharmaceutical Packaging LLC is notifying its distributors and customers in writing and is arranging/assisting for return of all recalled products to Inmar Pharmaceutical Services.

Providers can review the FDA’s full press release here.