Written by:Eli Ben-Yehuda, March 6, 2019

In the last two weeks, we have seen Pfizer, a major pharmaceutical company, recall their hypertension medication Valsartan. This week 3 more U.S pharmaceutical companies have joined the ranks. For almost one year now we have seen ACE inhibitors recall by major pharmaceutical companies – one recall after another for the same problem. But the problem is not going away and the recalls continue to grow. What is the problem? The medications are tainted with a known cancer-causing agent.

Torrent & Hetero-Cambo Pharmaceutical Recall

Torrent again expands its voluntary recall of losartan; Hetero also voluntarily recalls losartan.

Torrent Pharmaceuticals Limited is further expanding its voluntary recall to include 114 additional lots. These include lots of losartan potassium and losartan potassium/hydrochlorothiazide combination tablets. This recall is due to unacceptable amounts of N-Methylnitrosobutyric acid (NMBA) in the losartan active pharmaceutical ingredient manufactured by Hetero Labs Limited.

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Today, the agency also issued a press release to provide additional information about its ongoing investigation and another voluntary recall by Hetero/Camber Pharmaceuticals. This was announced on February 28, of 87 lots of losartan potassium tablets (25 mg, 50 mg, and 100 mg). The recalled losartan potassium and losartan potassium/hydrochlorothiazide tablets are also manufactured by Hetero, which is distributed by Camber, and contain the impurity NMBA.

Torrent and Hetero/Camber are only recalling lots of losartan-containing medication with NMBA above the interim acceptable intake limits of 0.96 parts per million (ppm).

The agency also updated the list of losartan products under recall.

Aurobindo expands its voluntary recall of valsartan and amlodipine/valsartan

Aurobindo Pharma USA is expanding its voluntary recall to include 38 additional lots of valsartan and amlodipine/valsartan combination tablets. The recall is due to unacceptable amounts of N-Nitrosodiethylamine (NDEA) found in the medicine.

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Aurobindo is only recalling lots of valsartan-containing medication where NDEA has been detected above the interim acceptable intake limit of 0.083 parts per million. FDA is working with manufacturers to reduce and remove nitrosamines from angiotensin II receptor blockers (ARBs).

The agency also updated the valsartan products under recall

FDA updates a table of interim limits for nitrosamine impurities in ARBs Update the FDA is posting the updated table of interim acceptable intake limits for nitrosamine impurities to reflect N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) limits, which are the same as those for NDMA.

The agency will use the interim limits below to recommend manufacturers conduct a voluntary recall if laboratory testing confirms the presence of nitrosamine impurities in finished drug products.

The FDA is working with industry and international regulators to ensure products entering the market do not contain these impurities, but we are tolerating the impurities below the level established in the table for a short period of time to avoid a possible shortage of ARBs.

Not all ARB products contain NDMA, NDEA or NMBA impurities, so pharmacists may be able to provide an alternative medication not affected by the recalls, or health care professionals may prescribe a different medication that treats the same condition.

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Macleods Pharmaceuticals Recall

FDA is alerting patients and health care professionals to a voluntary recall of one lot of losartan potassium/hydrochlorothiazide (HCTZ) 100mg/25mg combination tablets manufactured by Macleods Pharmaceuticals. The recall is due to unacceptable amounts of N-Nitrosodiethylamine (NDEA) found in the medicine made with active pharmaceutical ingredient manufactured by Hetero Labs Limited.

Macleods is only recalling lots of losartan-containing medication where NDEA has been detected above the interim acceptable intake limit of 0.27 parts per million. FDA is working with manufacturers to reduce and remove nitrosamines from angiotensin II receptor blockers (ARBs).

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What should patients know
  • Continue taking your current medicine until your doctor or pharmacist gives you a replacement or a different treatment option.
  • Not all valsartan-containing medications are affected and being recalled.
  • If you are taking any medication containing valsartan, compare the information on your prescription bottle with the information in this list (company, National Drug Code, lot number) to determine if your current medicine has been recalled. If you are not certain, contact your pharmacist.
  • If you have medicine included in the recall, contact your pharmacist. The pharmacist may The pharmacist may be able to provide you with valsartan made by another company. If not, contact your doctor immediately to discuss other treatment options.
What health care professionals should know:
  • FDA has determined the recalled valsartan products pose an unnecessary risk to patients. Therefore, FDA recommends patients use valsartan-containing medicines made by other companies or consider other available treatment options for the patient’s medical condition.
  • If you have medication samples from these companies, quarantine the products and do not provide them to patients.
  • Consumers and health care professionals should report any adverse reactions with valsartan-containing products, to the FDA’s MedWatch program to help the agency better understand the scope of the problem:

Complete and submit the report online at www.fda.gov/medwatch/report.htm Download and complete the appropriate form, then submit it via fax at 1-800-FDA-0178 be able to provide you with valsartan made by another company. If not, contact your doctor immediately to discuss other treatment options.

 

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