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FDA: Blood pressure medicines recalled due to 'possible process impurity, contaminant'

Posted: 8:45 AM, Mar 18, 2019
Updated: 2019-03-18 13:43:31-04
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EARTH CITY, Missouri — According to the Food and Drug Administration , two blood pressure medicines have been voluntarily recalled due to "a possible process impurity or contaminant in an active pharmaceutical ingredient."

Missouri pharmaceutical company, Legacy Pharmaceutical Packaging, LLC is recalling 40 repackaged lots of Losartan Potassium Tablets USP 25mg, 50mg, and 100mg, as well as three lots of Losartan Potassium USP 25 mg, 50 mg, and 100mg, the FDA press release stated.

Legacy's recall comes after another pharmaceutical company, Camber Pharmaceuticals, issued a voluntary recall on Losartan Tablets, USP.

The FDA said trace amounts of N-Nitroso N-Methyl 4-aminobutyric acid (NMBA), which is a potential human carcinogen.

Legacy says they have not received any reports of adverse events related to the recall, the FDA said.

The affected Losartan Potassium lots are:

LEGACY NDC#Name and StrengthCountLegacy Lot #Expiry
68645-577-54Losartan Potassium Tablets USP 25 mg3018095210/2019
68645-577-54Losartan Potassium Tablets USP 25 mg3018095312/2019
68645-577-54Losartan Potassium Tablets USP 25 mg3018108609/2019
68645-577-54Losartan Potassium Tablets USP 25 mg3018157201/2020
68645-578-54Losartan Potassium Tablets USP 50 mg3018092109/2019
68645-578-54Losartan Potassium Tablets USP 50 mg3018092210/2019
68645-578-54Losartan Potassium Tablets USP 50 mg3018092311/2019
68645-578-54Losartan Potassium Tablets USP 50 mg3018092411/2019
68645-578-54Losartan Potassium Tablets USP 50 mg3018111811/2019
68645-578-54Losartan Potassium Tablets USP 50 mg3018111910/2019
68645-578-54Losartan Potassium Tablets USP 50 mg3018140711/2019
68645-578-54Losartan Potassium Tablets USP 50 mg3018140812/2019
68645-578-54Losartan Potassium Tablets USP 50 mg3018157302/2020
68645-578-54Losartan Potassium Tablets USP 50 mg3018172502/2020
68645-578-54Losartan Potassium Tablets USP 50 mg3018172602/2020
68645-578-54Losartan Potassium Tablets USP 50 mg3018194803/2020
68645-578-54Losartan Potassium Tablets USP 50 mg3018196002/2020
68645-578-54Losartan Potassium Tablets USP 50 mg3018238503/2020
68645-578-54Losartan Potassium Tablets USP 50 mg3018238603/2020
68645-578-54Losartan Potassium Tablets USP 50 mg3018238703/2020
68645-579-54Losartan Potassium Tablets USP 100 mg3018088611/2019
68645-579-54Losartan Potassium Tablets USP 100 mg3018088712/2019
68645-579-54Losartan Potassium Tablets USP 100 mg3018088812/2019
68645-579-54Losartan Potassium Tablets USP 100 mg3018090512/2019
68645-579-54Losartan Potassium Tablets USP 100 mg3018112309/2019
68645-579-54Losartan Potassium Tablets USP 100 mg3018112410/2019
68645-579-54Losartan Potassium Tablets USP 100 mg3018112508/2019
68645-579-54Losartan Potassium Tablets USP 100 mg3018135111/2019
68645-579-54Losartan Potassium Tablets USP 100 mg3018135212/2019
68645-579-54Losartan Potassium Tablets USP 100 mg3018155111/2019
68645-579-54Losartan Potassium Tablets USP 100 mg3018162806/2020
68645-579-54Losartan Potassium Tablets USP 100 mg3018162906/2020
68645-579-54Losartan Potassium Tablets USP 100 mg3018172706/2020
68645-579-54Losartan Potassium Tablets USP 100 mg3018172806/2020
68645-579-54Losartan Potassium Tablets USP 100 mg3018189003/2020
68645-579-54Losartan Potassium Tablets USP 100 mg3018189106/2020
68645-579-54Losartan Potassium Tablets USP 100 mg3018189706/2020
68645-579-54Losartan Potassium Tablets USP 100 mg3018211403/2020
68645-579-54Losartan Potassium Tablets USP 100 mg3018211906/2020
68645-579-54Losartan Potassium Tablets USP 100 mg3018212006/2020

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