April 24, 2020
Golden State Medical Supply Inc. is recalling a half-dozen lots of losartan potassium tablets because the impurity N-Methylnitrosobutyric acid (NMBA) was detected in an active ingredient used to manufacture the drug, according to the April 22, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects losartan potassium tablets, 25 mg, in 30-count bottles (NDC 60429-316-30), 90-count bottles (NDC 60429-316-90), and 1000-count bottles (NDC 60429-316-10) from the following lots: GS018406 (Exp. 6/30/20), GS018858 (Exp. 7/31/20), GS019108 (Exp. 7/31/20), GS018521 (Exp. 7/31/20), GS018605 (Exp. 7/31/20), and GS018911 (Exp. 7/31/20).
The tablets were manufactured by Arrow Pharm (Malta) Ltd., packaged by Golden State Medical Supply Inc., and distributed throughout the United States.
Golden State Medical Supply Inc. voluntarily initiated the recall April 3, 2020. The FDA designated the recall Class II on April 13, 2020, signaling use of the tablets could cause temporary or medically reversible adverse health consequences. Although remote, a possibility of serious harm also exists.
Losartan is a prescription angiotensin receptor blocker used to treat hypertension and to protect kidneys from diabetes-related damage.