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Teva Pharmaceuticals recalls Losartan Potassium tablets

The product contains trace amounts of a potential human carcinogen

Photo
Photo source: FDA
Teva Pharmaceuticals USA is recalling 35 lots of bulk Losartan Potassium USP tablets used for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy, and nephropathy in Type 2 diabetic patients.

The product contains trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA), a potential human carcinogen.

The lots were sold exclusively to Golden State Medical Supply of Camarillo, Calif. Golden State Medical Supply packages this bulk product under its own label and distributes in retail bottles of 30, 90, and 1000 tablets.

Teva has not received any reports to date of adverse events related to the lots being recalled.

The finished product lots included in this voluntary recall and listed below were sold by Teva in bulk containers.

GSMS FG

NDCs

GSMS FG
NDC Description

GSMS

FG Product

Lots

GSMS FG

Expiration

Dates

60429-

318-90

Losartan Potassium,

Tablets,

USP, 100 mg,

90 Count Bottle

GS01404506/2019

60429-

318-90

Losartan Potassium,

Tablets,

USP, 100 mg,

90 Count Bottle

GS01430506/2019

60429-

318-10

Losartan Potassium,

Tablets,

USP, 100 mg,

1,000 Count Bottle

GS01405406/2019

60429-

318-90

Losartan Potassium,

Tablets,

USP, 100 mg,

90 Count Bottle

GS01404406/2019

60429-

316-10

Losartan Potassium

Tablets,

USP, 25 mg,

1,000 Count Bottle

GS01481706/2019

60429-

316-90

Losartan Potassium,

Tablets,

USP, 25 mg,

90 Count Bottle

GS01517206/2019

60429-

316-10

Losartan Potassium,

Tablets,

USP, 25 mg,

1,000 Count Bottle

GS01520406/2019

60429-

318-10

Losartan Potassium,

Tablets,

USP, 100 mg,

1,000 Count Bottle

GS01633812/2019

60429-

318-10

Losartan Potassium,

Tablets,

USP, 100 mg,

1,000 Count Bottle

GS01634101/2020

60429-

318-10

Losartan Potassium,

Tablets,

USP, 100 mg,

1,000 Count Bottle

GS01634201/2020

60429-

318-10

Losartan Potassium,

Tablets,

USP, 100 mg,

1,000 Count Bottle

GS01634301/2020

60429-

318-10

Losartan Potassium,

Tablets,

USP, 100 mg,

1,000 Count Bottle

GS01634401/2020

60429-

318-10

Losartan Potassium,

Tablets,

USP, 100 mg,

1,000 Count Bottle

GS01634501/2020

60429-

318-90

Losartan Potassium,

Tablets,

USP, 100 mg,

90 Count Bottle

GS01653501/2020

60429-

318-90

Losartan Potassium,

Tablets,

USP, 100 mg,

90 Count Bottle

GS01652401/2020

60429-

318-10

Losartan Potassium,

Tablets,

USP, 100 mg,

1,000 Count Bottle

GS01653901/2020

60429-

318-10

Losartan Potassium,

Tablets,

USP, 100 mg,

1,000 Count Bottle

GS01696901/2020

60429-

318-10

Losartan Potassium,

Tablets,

USP, 100 mg,

1,000 Count Bottle

GS01697301/2020

60429-

318-10

Losartan Potassium,

Tablets,

USP, 100 mg,

1,000 Count Bottle

GS01733701/2020

60429-

318-90

Losartan Potassium,

Tablets,

USP, 100 mg

90 Count Bottle

GS01738402/2020

60429-

318-90

Losartan Potassium,

Tablets,

USP, 100 mg,

90 Count Bottle

GS01738501/2020

60429-

318-90

Losartan Potassium,

Tablets,

USP, 100 mg,

90 Count Bottle

GS01753901/2020

60429-

318-90

Losartan Potassium,

Tablets,

USP, 100 mg,

90 Count Bottle

GS01754001/2020

60429-

318-90

Losartan Potassium,

Tablets,

USP, 100 mg,

90 Count Bottle

GS01754301/2020

60429-

318-90

Losartan Potassium,

Tablets,

USP, 100 mg,

90 Count Bottle

GS01754201/2020

60429-

318-10

Losartan Potassium,

Tablets,

USP, 100 mg,

1,000 Count Bottle

GS01852402/2020

60429-

318-90

Losartan Potassium,

Tablets,

USP, 100 mg,

90 Count Bottle

GS01798402/2020

60429-

318-90

Losartan Potassium,

Tablets,

USP, 100 mg,

90 Count Bottle

GS01798502/2020

60429-

318-90

Losartan Potassium,

Tablets,

USP, 100 mg,

90 Count Bottle

GS01798602/2020

60429-

318-90

Losartan Potassium,

Tablets,

USP, 100 mg,

90 Count Bottle

GS01826302/2020

60429-

318-90

Losartan Potassium,

Tablets,

USP, 100 mg,

90 Count Bottle

GS01826402/2020

60429-

316-90

Losartan Potassium,

Tablets,

USP, 25 mg,

90 Count Bottle

GS01763402/2020

60429-

316-90

Losartan Potassium,

Tablets,

USP, 25 mg,

90 Count Bottle

GS01765302/2020

60429-

316-90

Losartan Potassium,

Tablets,

USP, 25 mg,

90 Count Bottle

GS01798002/2020

60429

-316-30

Losartan Potassium,

Tablets,

USP, 25 mg,

30 Count Bottle

GS01798102/2020

60429-

318-90

Losartan Potassium,

Tablets,

USP, 100 mg,

90 Count Bottle

GS01826502/2020

60429-

316-90

Losartan Potassium,

Tablets,

USP, 25 mg,

90 Count Bottle

GS01672602/2020

60429-

316-30

Losartan Potassium,

Tablets,

USP, 25 mg,

30 Count Bottle

GS01695802/2020

60429-

316-90

Losartan Potassium,

Tablets,

USP, 25 mg,

90 Count Bottle

GS01704502/2020

60429-

316-90

Losartan Potassium,

Tablets,

USP, 25 mg,

90 Count Bottle

GS01727602/2020

60429-

316-30

Losartan Potassium,

Tablets,

USP, 25 mg,

30 Count Bottle

GS01734102/2020

60429-

316-10

Losartan Potassium,

Tablets,

USP, 25 mg,

1,000 Count Bottle

GS01831802/2020

60429-

316-10

Losartan Potassium,

Tablets,

USP, 25 mg,

1,000 Count Bottle

GS01734202/2020

60429-

316-10

Losartan Potassium,

Tablets,

USP, 25 mg,

1,000 Count Bottle

GS01780802/2020

The bulk tablet lots were repackaged into 44 finished products lots for further distribution by Golden State Medical Supply under its product label.

The recalled tablets are described as:

  • Losartan Potassium tablets, USP 25 mg, are light-green, film-coated, teardrop-shaped biconvex tablet with “LK 25” on one side and ">" on the other side.
  • Losartan Potassium tablets, USP 100 mg, are dark green, film-coated, oval-shaped biconvex tablets with “LK100” on one side and ">" on the other side.

What to do

Patients taking Losartan Potassium tablets are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. The immediate risk of harm to a patient’s health is likely to be higher if the medicine is stopped abruptly without any alternative treatment.

Patients with medical-related questions, who wish to report an adverse event, or quality issues about the recalled products may contact Teva Medical Information by at (888)838-2872, option 3, then, option 4, Monday-Friday, 9:00AM – 5:00PM (ET) with voicemail available 24 hours/day, 7 days/week, or by email at druginfo@tevapharm.com.

Patients wishing to return product may contact Teva’s product recall processor (Inmar) to obtain instructions and a return kit for returning their medication.

Contact Inmar at (877) 789-2065 from 9 am to 5 pm (ET) Monday – Friday) or by email Inmar at: tevarecalls@inmar.com.

Inmar will provide the materials needed to return their medication and instructions for reimbursement.

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