Ripple Effect: Repackaged Losartan Recalled Due to Impurity

Megan Brooks

March 18, 2019

Legacy Pharmaceutical Packaging LLC, based in Earth City, Missouri, has announced a nationwide recall to the consumer level of 40 repackaged lots of losartan tablets.

This latest recall in the ongoing saga of contaminated sartan products stems from Camber Pharmaceuticals' previously announced nationwide recall of losartan tablets found to contain trace amounts of the impurity N-nitroso-N-methyl-4-aminobutyric acid (NMBA) in the active pharmaceutical ingredient (API) made by Hetero Labs Ltd.

NMBA is a known animal and potential human carcinogen. To date, Legacy has not received any reports of adverse events related to this recall. The recalled product are as follows:

Recalled Products National Drug Code (NDC) Number
Losartan potassium, USP, 25 mg 68645-577-54
Losartan potassium, USP, 50 mg 68645-578-54
Losartan potassium, USP, 100 mg 68645-579-54

The 40 repackaged lot numbers are listed in a company announcement posted on the US Food and Drug Administration website.

Legacy Pharmaceuticals Packaging is notifying its distributors and customers in writing and is arranging for the return of recalled products. For questions about this recall, contact Stericycle weekdays from 9 AM to 5 PM CST at 1-888-275-0506.

Separately, Legacy Pharmaceutical Packaging has recalled three additional repackaged lots of losartan tablets (50 mg, 30-count bottles) to the consumer level. This recall stems from Torrent Pharmaceuticals' previously announced nationwide recall of losartan due to detection of trace amounts of NMBA manufactured by Hetero Labs.

The Legacy NDC for all three recalled lots is 68645-494-54 and the lot numbers are 180190 and 180191 (both with expiration dates of 10/2020) and 181597 (expiration of 02/2021).

Legacy is notifying its distributors and customers in writing about this recall and arranging for return of recalled products. More information about this recall is available by calling Inmar at 1-877-538-8443, weekdays from 9 AM to 5 PM EST.

The FDA maintains an updated list of recalled sartan products on its website. Adverse reactions or quality problems associated with the use of valsartan products should be reported to FDA's MedWatch Adverse Event Reporting Program.

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