Another hypertension tablet recalled due to impurity

This is the eighth recall

Another hypertension tablet recalled due to impurity
Tablet recall (Source: FDA)

(KPLC) - Legacy Pharmaceutical Packaging LLC. is recalling 40 repackaged lots of Losartan Tablets USP 25mg, 50mg, and 100mg due to a possible process impurity or contaminant in an active pharmaceutical ingredient, according to the FDA.

FDA says trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) were detected. NMBA is a potential human carcinogen.

Losartan Potassium USP is a prescription medication used to treat high blood pressure and congestive heart failure, FDA says. Products can be returned to the dispensing pharmacy.

Here are the affected products:

  • 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
  • 68645-578-5 4 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

These products were distributed by pharmacies nationwide, says the FDA. To date, there are no reports of adverse events.

See the full report HERE.

Losartan recall
Losartan recall (Source: FDA)

Here are the previous recalls:

1. Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide Tablets USP

5. Valsartan Tablets USP

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