Torrent Pharma Losartan Recall [US]


US FlagUS/Silver Spring: Torrent Pharma Losartan Recall [US]Torrent Pharmaceuticals Limited, an Ahmedabad, Gujarat establishment, expands its existing recalls from two (2) lots of Losartan Potassium Tablets USP to a total of ten (10) lots all unexpired batch/lots of due to suspected N-Nitrosodimethylamine (“NDMA”) contamination and consequential risks of Carcinogen damage and Cancer, all serious health hazards.

FDA: http://ht.ly/RmeV30ndMED

Direct link: https://www.fda.gov/Safety/Recalls/ucm629261.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Losartan Tablets are subject to this recall:

  • Losartan Potassium Tab, USP 100 mg, 30-count bottles, with a batch/lot designation of BO31C016 and an expiry date of 04/01/2019
  • Losartan Potassium Tab, USP 100 mg, 90-count bottles, with a batch/lot designation of BO31C016 and an expiry date of 04/01/2019
  • Losartan Potassium Tab, USP, sold in 100 mg, 1000-count bottles, with a batch/lot designation of 4DK3C005 and an expiry date of 04/01/2019
  • Losartan Potassium Tab, USP, sold in 100 mg,1000-count bottles, with a batch/lot designation of 4DK3C004 and an expiry date of 04/01/2019
  • Losartan Potassium Tab, USP, sold in 100 mg,1000-count bottles, with a batch/lot designation of 4DU3C040 and an expiry date of 10/01/2019
  • Losartan Potassium Tab, USP, sold in 100 mg, 1000-count bottles, with a batch/lot designation of 4DU3E049 and an expiry date of 05/01/2021
  • Losartan Potassium Tab, USP, sold in 100 mg, 1000-count bottles, with a batch/lot designation of 4DU3E050 and an expiry date of 05/01/2021
  • Losartan Potassium Tab, USP 50 mg, 30-count bottles, with a batch/lot designation of 4L67C035 and an expiry date of 10/01/2019
  • Losartan Potassium Tab, USP 50 mg, 90-count bottles, with a batch/lot designation of 4L67C035 and an expiry date of 10/01/2019
  • Losartan Potassium Tab, USP 50 mg, 90-count bottles, sold in 50 mg, 1000-count bottles, with a batch/lot designation of 4L67C036 and an expiry date of 10/01/2019
  • Losartan Potassium Tab, USP, with a batch/lot designation of 4O50C005 and an expiry date of 11/01/2019
  • Losartan Potassium Tab, USP 25 mg, 90-count bottles, with a batch/lot designation of 4O49C013 and an expiry date of 09/01/2019

==> Please note: NDC information is also available for each recalled Losartan Potassium product on the Web site identified above.

NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution and industrial processes, and has been classified as a Probable human Carcinogen as per International Agency for Research on Cancer (“IARC”) classification.

According to the FDA, Losartan is used to treat Hypertension, Hypertensive patients with Left Ventricular Hypertrophy and for the treatment of Nephropathy in Type 2 Diabetic patients. People who are taking Losartan should continue on their medication, as the risk of harm to your health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

Consumers should contact their doctor for further guidance and potential change of treatment before they stop taking this product. Pharmacies and healthcare facilities that have product being recalled should stop using and dispensing the product immediately.

==> Never stop taking your prescription medications, including Losartan, without the knowledge and approval of your personal physician or other MD familiar with your medical history, current health status and other drugs, medications and supplements you may be consuming. Failure to do so, may result in a serious drug interaction, side effect, complication, personal injury and/or death.

If you believe you have purchased or have in your possession any of the recalled drugs, please do not consume them directly nor use them as an ingredient in another treatment. Instead, return the drugs to the pharmacy or other outlet where you purchased it for a full refund or exchange.

==> To see other recalls and notifications caused by contaminated, adulterated or mislabeled Losartan, please search for “Losartan” using the Search Box at the top of this page.

==> To see other recalls and notifications caused by suspected Carcinogenic contamination, please search for “Cancer” or more generically, “fragment” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by Torrent Pharmaceuticals, Inc., please search for “Torrent” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or distributed by Torrent Pharma please search for “Torrent” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 11012-2019
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
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General information:
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Visit the Living Safely site:
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==> http://www.fda.gov/Safety/Recalls/ArchiveRecalls/default.htm

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E. & O. E.

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