Legacy Pharmaceutical Expands Losartan Recall

Patrice Wendling

April 25, 2019

Legacy Pharmaceutical Packaging LLC is adding one additional lot to its consumer-level recall of three repackaged lots of losartan potassium USP 50 mg.

The affected tablets were packaged in 30-count bottles bearing the NDC number 68645-494-54 and distributed by pharmacies nationwide.

The recall was prompted by Torrent Pharmaceuticals' nationwide recall just days ago of 104 lots of losartan tablets due to the detection of trace amounts of the potential carcinogen N-Methylnitrosobutyric acid (NMBA) in an active pharmaceutical ingredient manufactured by Hetero Labs Limited.

To date, Legacy Pharmaceutical has not received any reports of adverse events related to this recall, the US Food and Drug Administration (FDA) reported.

Legacy is notifying its distributors and customers in writing and is arranging for return of all recalled products to Inmar Pharmaceutical Services. Instructions for returning recalled products are provided in the recall letter.

Consumers with questions regarding the recall can contact Inmar at 1-877-538-8443, Monday through Friday, 9 AM to 5 PM EST. Consumers should contact their physician or healthcare provider if they have questions related to taking or using the tablets.

Detailed information, including NDC and lot numbers, on all four lots of losartan recalled by Legacy is available here.

The FDA's list of recalled losartan products, updated on April 18, is available here.

Follow Patrice Wendling on Twitter: @pwendl. For more from theheart.org | Medscape Cardiology, follow us on Twitter and Facebook.


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