The FDA reported that they have found traces of unexpected impurities in certain batches of Losartan. The impurity that has been detected is N-Methylnitrosobutyric acid or NMBA. The company is only recalling batches of Losartan that contain more than the acceptable daily intake levels of NMBA set by the FDA.
Losartan is an antihypertensive drug used to treat high blood pressure. It is most commonly used for treating hypertension, left ventricular hypertrophy, and nephropathy for type 2 diabetics. There have been over 75 blood pressure medications recalled over the past year due to cancer-causing chemicals. The most common drugs include valsartan, losartan, and irbesartan.
Taking the contaminated Valsartan with exposure to N-nitrosodimethylamine (NDMA) has been known to produce side effects that include:
- Upper respiratory infections,
- Flu symptoms,
- Tiredness and fatigue,
- Dizziness and lightheadedness,
- Nausea and diarrhea,
- Sore throat, sneezing, stuffy or runny nose, cough and other cold symptoms,
- Blurred vision
- Stomach pain
- Joint pain
- Back pain
- Unexpected weight loss
- Swelling around the eyes or lips
More serious side effects involve:
- Rapid weight loss
- Unusual increase urinating volume
- Shortness of breath
- High potassium response including a tingling sensation, muscle weakness, week pulse, or slowed heart rate.
- Chest flutters, pounding heart beats, loss of appetite, increase thirst, confusion weakness,
- The sensation of passing out.
Torrent Pharmaceuticals Limited is now notifying all of their current distributors and customers to immediately discontinue distribution or use of the recalled product batches.
The products included in the recall expansion are below:
|NDC||Product Name, Strength and Package Count||Batch Number||Expiration Date|
|13668-409-10||Losartan Potassium Tablets, USP 50mg, 1000 count||4DU2E009||12/31/2020|
|13668-115-90||Losartan Potassium Tablets, USP 100mg, 90 count||4DU3E009||12/31/2020|
|13668-115-10||Losartan Potassium Tablets, USP 100mg, 1000 count||4DU3E018||02/28/2021|
|13668-116-90||Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count||BEF7D051||11/30/2020|
|13668-118-90||Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count.||4P04D007||07/31/2020|
If you or a loved one has taken losartan and have experienced any heath issues that may be related to these drugs, please contact the McEwen Law Firm right away.Officials are urging people who have or are currently taking losartan to contact their health physician or pharmacist to receive alternative treatment or to make sure the product you are taking is safe.
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