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 Strength | Count | Legacy Lot # | Expiry |
---|---|---|---|---|
68645-577-54 | Losartan Potassium Tablets USP 25 mg | 30 | 180952 | 10/2019 |
68645-577-54 | Losartan Potassium Tablets USP 25 mg | 30 | 180953 | 12/2019 |
68645-577-54 | Losartan Potassium Tablets USP 25 mg | 30 | 181086 | 09/2019 |
68645-577-54 | Losartan Potassium Tablets USP 25 mg | 30 | 181572 | 01/2020 |
68645-578-54 | Losartan Potassium Tablets USP 50 mg | 30 | 180921 | 09/2019 |
68645-578-54 | Losartan Potassium Tablets USP 50 mg | 30 | 180922 | 10/2019 |
68645-578-54 | Losartan Potassium Tablets USP 50 mg | 30 | 180923 | 11/2019 |
68645-578-54 | Losartan Potassium Tablets USP 50 mg | 30 | 180924 | 11/2019 |
68645-578-54 | Losartan Potassium Tablets USP 50 mg | 30 | 181118 | 11/2019 |
68645-578-54 | Losartan Potassium Tablets USP 50 mg | 30 | 181119 | 10/2019 |
68645-578-54 | Losartan Potassium Tablets USP 50 mg | 30 | 181407 | 11/2019 |
68645-578-54 | Losartan Potassium Tablets USP 50 mg | 30 | 181408 | 12/2019 |
68645-578-54 | Losartan Potassium Tablets USP 50 mg | 30 | 181573 | 02/2020 |
68645-578-54 | Losartan Potassium Tablets USP 50 mg | 30 | 181725 | 02/2020 |
68645-578-54 | Losartan Potassium Tablets USP 50 mg | 30 | 181726 | 02/2020 |
68645-578-54 | Losartan Potassium Tablets USP 50 mg | 30 | 181948 | 03/2020 |
68645-578-54 | Losartan Potassium Tablets USP 50 mg | 30 | 181960 | 02/2020 |
68645-578-54 | Losartan Potassium Tablets USP 50 mg | 30 | 182385 | 03/2020 |
68645-578-54 | Losartan Potassium Tablets USP 50 mg | 30 | 182386 | 03/2020 |
68645-578-54 | Losartan Potassium Tablets USP 50 mg | 30 | 182387 | 03/2020 |
68645-579-54 | Losartan Potassium Tablets USP 100 mg | 30 | 180886 | 11/2019 |
68645-579-54 | Losartan Potassium Tablets USP 100 mg | 30 | 180887 | 12/2019 |
68645-579-54 | Losartan Potassium Tablets USP 100 mg | 30 | 180888 | 12/2019 |
68645-579-54 | Losartan Potassium Tablets USP 100 mg | 30 | 180905 | 12/2019 |
68645-579-54 | Losartan Potassium Tablets USP 100 mg | 30 | 181123 | 09/2019 |
68645-579-54 | Losartan Potassium Tablets USP 100 mg | 30 | 181124 | 10/2019 |
68645-579-54 | Losartan Potassium Tablets USP 100 mg | 30 | 181125 | 08/2019 |
68645-579-54 | Losartan Potassium Tablets USP 100 mg | 30 | 181351 | 11/2019 |
68645-579-54 | Losartan Potassium Tablets USP 100 mg | 30 | 181352 | 12/2019 |
68645-579-54 | Losartan Potassium Tablets USP 100 mg | 30 | 181551 | 11/2019 |
68645-579-54 | Losartan Potassium Tablets USP 100 mg | 30 | 181628 | 06/2020 |
68645-579-54 | Losartan Potassium Tablets USP 100 mg | 30 | 181629 | 06/2020 |
68645-579-54 | Losartan Potassium Tablets USP 100 mg | 30 | 181727 | 06/2020 |
68645-579-54 | Losartan Potassium Tablets USP 100 mg | 30 | 181728 | 06/2020 |
68645-579-54 | Losartan Potassium Tablets USP 100 mg | 30 | 181890 | 03/2020 |
68645-579-54 | Losartan Potassium Tablets USP 100 mg | 30 | 181891 | 06/2020 |
68645-579-54 | Losartan Potassium Tablets USP 100 mg | 30 | 181897 | 06/2020 |
68645-579-54 | Losartan Potassium Tablets USP 100 mg | 30 | 182114 | 03/2020 |
68645-579-54 | Losartan Potassium Tablets USP 100 mg | 30 | 182119 | 06/2020 |
68645-579-54 | Losartan Potassium Tablets USP 100 mg | 30 | 182120 | 06/2020 |
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