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Posted on: March 5, 2019 at 12:48 pm
Last updated: March 12, 2019 at 2:50 pm

If you’ve been prescribed a high blood pressure drug, check your medication label immediately. A batch of a common hypertension drug, Losartan potassium has been voluntarily recalled for your safety.

Macleods Pharmaceuticals Limited, the makers of Losartan potassium/ Hydrochlorothiazide have issued a voluntary recall of their commonly prescribed drug due to tests finding trace amounts of an unexpected impurity, N-nitrosodiethylamine (NDEA).

NDEA is a suspected human carcinogen which is regularly used in scientific lab studies to induce liver tumors in animal research. The chemical is sometimes used as an additive in gasoline and industrial lubricant as well as a stabilizer in plastics. (1)

About Macleods Pharmaceuticals Limited

Along with Losartan potassium, Macleods Pharmaceuticals Limited also manufactures medications for cardiovascular health, diabetes, orthopedics, gynecology, respiration, and oncology, all from their FDA regulated facilities in India.

You may recognize some of their other products, which include:

  • Ultracet, Ultram (pain killers)
  • Azor, Norvasc, Atacand, Avalide, Avapro, Hyzaar, Cozaar, Benicar, Tamiflu, Revatio, Diovan (high blood pressure medications)
  • Celebrex (NSAID)
  • Cymbalta, Lexapro, Effexor XR (antidepressant)
  • Lunesta (anti-insomnia)
  • Xyzal (allergy pill)
  • Levaquin (antibacterial)
  • Glucophage (anti-diabetic)
  • Singulair (anti-asthmatic)
  • Protonix (antacid)
  • Seroquel (antipsychotic)
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Their corporate social responsibility policy states one of their commitments is “To sustain and continuously improve standards of Environment, Health and Safety in the Society at all levels towards and to support programs and initiatives, internal or external, for the prevention of illness and combating of diseases as may be considered appropriate from time to time.”(2)

How to Check Your Prescription Label

Look for the following information on your prescription label. If you’re unsure about what you see, you can ask your pharmacist for assistance. (3)

NDC: 33342-0052-10

Manufacturer: Macleods Pharmaceuticals Limited

Product Description: Losartan Potassium/ Hydrochlorothiazide combination tablets 100mg/25mg, 90 count bottles

Lot/Batch: BLM715A

Expiration Date: Jul-2019

Editors Note: UPDATE

Another, much larger recall was made as of March 1st, 2019 (6). This was a voluntary recall by Torrent Pharmaceuticals Limited. 60 lots of Losartan potassium tablets and 54 lots of Losartan potassium/ hydrochlorothiazide tablets were recalled. Trace amounts of an unwanted impurity were also found in these batches. The impurity is known as N-Methylnitrosobutyric acid (NMBA).  These drugs were manufactured by Hetero Labs Limited. Please Look for the following information on your prescription label. If you’re unsure about what you see, you can ask your pharmacist for assistance.

NDC Name and Strength Count Lot# Expiry
31722-700-90 Losartan Potassium Tablets USP 25 mg 90 LOP17026B Sep-19
31722-700-90 Losartan Potassium Tablets USP 25 mg 90 LOP17050 Sep-19
31722-700-90 Losartan Potassium Tablets USP 25 mg 90 LOP17051 Sep-19
31722-700-90 Losartan Potassium Tablets USP 25 mg 90 LOP17052 Sep-19
31722-700-90 Losartan Potassium Tablets USP 25 mg 90 LOP17053 Sep-19
31722-700-90 Losartan Potassium Tablets USP 25 mg 90 LOP17061 Oct-19
31722-700-90 Losartan Potassium Tablets USP 25 mg 90 LOP18035 Dec-19
31722-700-90 Losartan Potassium Tablets USP 25 mg 90 LOP18036 Dec-19
31722-700-05 Losartan Potassium Tablets USP 25 mg 500 LOP17026 Sep-19
31722-700-10 Losartan Potassium Tablets USP 25 mg 1000 LOP17006 May-19
31722-700-10 Losartan Potassium Tablets USP 25 mg 1000 LOP17025 Sep-19
31722-700-10 Losartan Potassium Tablets USP 25 mg 1000 LOP17068 Oct-19
31722-700-10 Losartan Potassium Tablets USP 25 mg 1000 LOP18037 Dec-19
31722-700-10 Losartan Potassium Tablets USP 25 mg 1000 LOP18038 Dec-19
31722-700-10 Losartan Potassium Tablets USP 25 mg 1000 LOP18039 Dec-19
31722-700-10 Losartan Potassium Tablets USP 25 mg 1000 LOP18057 Jan-20
31722-701-30 Losartan Potassium Tablets USP 50 mg 30 LOP17028C Sep-19
31722-701-30 Losartan Potassium Tablets USP 50 mg 30 LOP17064A Nov-19
31722-701-90 Losartan Potassium Tablets USP 50 mg 90 LOP17027 Sep-19
31722-701-90 Losartan Potassium Tablets USP 50 mg 90 LOP17063 Nov-19
31722-701-90 Losartan Potassium Tablets USP 50 mg 90 LOP17093 Nov-19
31722-701-90 Losartan Potassium Tablets USP 50 mg 90 LOP17094 Dec-19
31722-701-90 Losartan Potassium Tablets USP 50 mg 90 LOP17095 Dec-19
31722-701-90 Losartan Potassium Tablets USP 50 mg 90 LOP17097A Dec-19
31722-701-90 Losartan Potassium Tablets USP 50 mg 90 LOP17105 Dec-19
31722-701-90 Losartan Potassium Tablets USP 50 mg 90 LOP17107 Dec-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17004 Dec-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17028B Sep-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17048 Oct-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17049 Oct-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17056 Nov-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17073 Nov-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17074 Nov-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17076 Nov-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP17096 Dec-19
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP18077A Feb-20
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP18078 Feb-20
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP18079 Feb-20
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP18080 Feb-20
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP18081 Mar-20
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP18084 Mar-20
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP18095 Mar-20
31722-701-10 Losartan Potassium Tablets USP 50 mg 1000 LOP18096 Mar-20
31722-702-30 Losartan Potassium Tablets USP 100 mg 30 LOP17011 Aug-19
31722-702-30 Losartan Potassium Tablets USP 100 mg 30 LOP17087 Nov-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP17012 Aug-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP17013 Aug-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP17042 Oct-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP17043 Oct-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP17044 Nov-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP17045 Nov-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP18024 Dec-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP18025 Dec-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP18026 Dec-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP18027 Dec-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP18028 Dec-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP18029 Dec-19
31722-702-90 Losartan Potassium Tablets USP 100 mg 90 LOP18030 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP17005 May-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP17014 Aug-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP17016 Sep-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP17023 Sep-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP17083 Oct-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP17084 Nov-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP17085 Nov-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP17086 Nov-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18021 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18022 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18023 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18031 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18032 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18033 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18050 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18051 Dec-19
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18109 Mar-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18111 Mar-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18122 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18123 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18124 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18125 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18126 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18127 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18128 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18129 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18130 Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18131C Jun-20
31722-702-10 Losartan Potassium Tablets USP 100 mg 1000 LOP18133 Jun-20
List obtained from U.S. Food and Drug Administration 

What to Do if Your Medication is Affected by the Recall

To date, no adverse effects have been reported to the FDA. If your medication is affected by the recall, contact your doctor immediately. The FDA strongly advises against stopping your medication without medical supervision, since the negative repercussions of ceasing your prescription could outweigh the potential risk of side effect. (3)

What’s more, you can report any side effects to the FDA via their MedWatch Adverse Event Reporting system by using any of these means:

  1. Complete and submit the report Online: www.fda.gov/medwatch/report.htm
  2. Regular Mail or Fax: Download from www.fda.gov/MedWatch/getforms.htm or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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You can also direct any questions about this drug recall by calling Qualanex, the company which is handling the recall on Macleods’ behalf, at 888-280-2042 during business hours or emailing recall@qualanex.com any time.

Who Uses Losartan Potassium?

Doctors prescribe Losartan potassium as a treatment for hypertension (high blood pressure) and nephropathy in people with Type 2 diabetes. The drug relaxes blood vessels and increases circulation, which lowers blood pressure. (4)

2010 research paper lists additional uses as decreasing the risk of stroke, reducing proteinuria and uric acid levels, lowering blood clot risk, and treating left ventricular hypertrophy. (5)

Common side effects of Losartan potassium can include: (4)

  • dizziness
  • upper respiratory infection
  • nasal congestion
  • back pain

If you’re interested in learning more about effective ways to help manage high blood pressure naturally, talk to your doctor about whether any of these holistic approaches is right for you:

8 Powerful Foods for Helping to Manage Blood Pressure

Blood Pressure Lowering Breathing Exercises to Try at Home

10 Stress-busting Tips

A Simple Fitness Routine to Do Every Evening

Disclaimer: This information is not intended to be a substitute for professional medical advice, diagnosis or treatment and is for information only. Always seek the advice of your physician or another qualified health provider with any questions about your medical condition and/or current medication. Do not disregard professional medical advice or delay seeking advice or treatment because of something you have read here.

Sources:

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1. https://pubchem.ncbi.nlm.nih.gov/compound/n-nitrosodiethylamine

2. http://www.macleodspharma.com/about.asp

3. https://www.fda.gov/Safety/Recalls/ucm631880.htm

4. https://www.medicalnewstoday.com/articles/324028.php

5. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3108782/

6. https://www.fda.gov/Safety/Recalls/ucm632509.htm

 

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Emese Graham
Health Expert
Emese believes women's health, mental health, and spiritual health really matter, so she jumps at the chance to bring those conversations to light. In her spare time, Emese enjoys finding challenging workout videos on Youtube (because gyms are hard for introverts), and she's all about getting creative in the kitchen and making recipes a little different every time - who needs measuring cups?

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