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)
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
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:
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- 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
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)
A 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
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:
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
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