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Blood Pressure Tablets Recalled
Another firm is recalling lots of prescription losartan potassium tablets due to azido impurity levels that are above acceptable limits. Strides Pharma Inc voluntarily initiated the call, which was included in the June 8, 2022, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects the following products, which were manufactured by Vivimed Life Sciences Private Limited in India and distributed by Strides Pharma Inc in East Brunswick, NJ.
- 200,407 bottles of losartan potassium tablets, 25 mg (NDC 64380-933-05 Lots 7901007A), (Exp. Date 6/22); Lots 7901144A,7901178A & 7901179A, (Exp. Date 9/22); Lots 7901246A & 7901247A, (Exp. Date 10/22); Lot 7901343A, (Exp. Date 12/22). NDC 64380-933-08 7901006A, (Exp. Date 6/22); 7901145A, and 7901180A, (Exp. Date 9/22) and 7901181A, (Exp. Date 10/22).
- 381,456 bottles of losartan potassium tablets, 50 mg (NDC 64380-934-05 7901146A, 7901147A, 7901148A &7901149A) (Exp. Date 9/22) 7901279A, (Exp. Date 11/22) 7901280A,7901281A,7901282A,7901283A,7901284A, 7901359A, 7901360A & 7901361A, (Exp. Date 12/22); 7901362A, 7901406A, 7901407A, 7901408A & 7901409A, Exp. Date 01/23 64380-934-08 7901008A & 7901009A, (Exp. Date 6/22); 7901150A & 7901151A, (Exp. Date 9/22); 7901285B, 7901286B, 7901287A, 7901288A, 7901289A, 7901290A , 7901291A, 7901292A, 7901293A, & 7901294A, (Exp. Date 11/22)
- 96,966 bottles of losartan potassium tablets, 100 mg, 64380-935-05 7901047B, 7901048B, 7901049B & 7901050B (Exp. Date 7/22) 7901185A, 7901186A, 7901187A & 7901188A, (Exp. Date 10/22) 7801250A, 7801251A & 7801252A (Exp. Date 11/22) 7901185A, 7901186A, 7901187A, 7901188A, (Exp. Date 10/22) 7901250A, 7901251A & 7901252A, (Exp. Date 11/22) 64380-935-08 7900813B, (Exp. Date 5/22) 7900814B, (Exp. Date 5/22) 7900908A, (Exp. Date 5/22) 7900935A, (Exp. Date 5/22) 7900936A, (Exp. Date 5/22) 7900937A, (Exp. Date 5/22) 7900938A, (Exp. Date 5/22) 7900939B, (Exp. Date 5/22)
The recall was initiated on May 16, 2022, and the FDA designated the recall Class II on May 28, 2022, communicating use of the affected tablets may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.
Last week, losartan recalls due to azido impurity levels were initiated by 3 firms and earlier this spring 2 more firms also recalled the product.
Losartan is a prescription medication used to treat high blood pressure.
