The FDA again adds more drugs to its valsartan recall list

The US Food and Drug Administration again...

Posted: Oct 25, 2018 2:59 PM
Updated: Oct 25, 2018 2:59 PM

The US Food and Drug Administration again added to its list of products that are included in the recall of drugs containing valsartan, a generic ingredient that helps people with high blood pressure and heart failure. That ingredient in the recalled drugs was tainted with a possible carcinogen.

The FDA testing of these products determined that an additional lot of brands sold under the name RemedyRepack needed to be added to the recall list.

Business and industry sectors

Business, economy and trade

Company activities and management

Consumer protection

Government organizations - US

Pharmaceutical industry

Pharmaceuticals and biotechnology

Pharmaceuticals and prescription drugs

Product management

Product recalls

Society

US Department of Health and Human Services

US federal departments and agencies

US Food and Drug Administration

Several pills that contain valsartan have been under a voluntary recall since July. The drugs were tainted with N-nitrosodimethylamine, or NDMA, an impurity that is considered a possible carcinogen by the US Environmental Protection Agency. It's an organic chemical used to make liquid rocket fuel and a byproduct from manufacturing some pesticides and processing fish. NDMA can be unintentionally introduced into manufacturing through certain chemical reactions.

Not all versions of the drugs have been recalled, but the FDA keeps a regularly updated list of the drugs that have been impacted.

The agency began testing valsartan products for the substance NDMA after it learned that Zhejiang Huahai Pharmaceuticals found it in several batches of its medications. The FDA also began testing for another impurity, N-Nitrosodiethylamine, or NDEA, after it was identified in three lots of the drugs made by Torrent Pharmaceuticals. NDEA is also a suspected human carcinogen. Not all batches of these medications have been found to be contaminated.

The FDA placed Zhejiang Huahai Pharmaceuticals on an import alert at the end of September, meaning all active pharmaceutical products and finished products made by the company will not be permitted to enter the US. The FDA made that decision after its recent inspection of the facility.

It's unclear exactly what the cancer risk is if you take the contaminated pills; the FDA believed the risk was low. It estimated that if 8,000 people took the highest dose of valsartan (320 mg) containing NDMA from these recalled batches daily for four years, there may be one additional case of cancer over the lifetimes of 8,000 people. Many patients take a much lower dose and therefore their risks are theoretically much lower.

The agency said it is continuing to run tests to evaluate the cancer risk from the contaminated pills.

What to do if you take a drug with valsartan

If you are worried your drug could be on the recall list, talk with your doctor or pharmacist before changing any routine with your medicine. Because not all valsartan drugs are involved in the recall, they might be able to switch you to a version of the drug made by another company. The FDA keeps a second list of valsartan products not currently recalled.

If you know your drug is on the recall list, the FDA suggests you continue taking it until your doctor or pharmacist provides a replacement.

The FDA said it will continue to test all products containing valsartan and similar drugs for the presence of impurities.

California Coronavirus Cases

Data is updated nightly.

Confirmed Cases: 292560

Reported Deaths: 6718
CountyConfirmedDeaths
Los Angeles1232563643
Riverside21957515
Orange20225376
San Diego17842406
San Bernardino16586293
Imperial7464125
Fresno728184
Alameda7245142
San Joaquin581761
Kern575987
Santa Clara5552165
Tulare5298148
Sacramento477678
Contra Costa424186
San Francisco407150
Ventura385850
Santa Barbara380830
San Mateo3743111
Marin323226
Stanislaus300450
Kings282338
Monterey227017
Solano192227
Merced162311
Sonoma148714
Placer97011
Madera8578
San Luis Obispo8453
Yolo76028
Santa Cruz5033
Napa4534
Sutter3234
San Benito3042
Butte2954
El Dorado2800
Lassen2670
Shasta1715
Humboldt1574
Nevada1551
Yuba1543
Glenn1530
Lake1001
Colusa980
Mendocino980
Tehama981
Calaveras610
Del Norte580
Tuolumne580
Mono491
Amador350
Inyo341
Siskiyou330
Mariposa311
Plumas150
Alpine20
Trinity20
Sierra10
Unassigned00
Chico
Clear
72° wxIcon
Hi: 98° Lo: 66°
Feels Like: 72°
Oroville
Clear
71° wxIcon
Hi: 99° Lo: 67°
Feels Like: 71°
Paradise
Clear
72° wxIcon
Hi: 91° Lo: 67°
Feels Like: 72°
Chester
Clear
51° wxIcon
Hi: 81° Lo: 53°
Feels Like: 51°
Red Bluff
Clear
73° wxIcon
Hi: 100° Lo: 67°
Feels Like: 73°
Willows
Clear
72° wxIcon
Hi: 102° Lo: 64°
Feels Like: 72°
The seasonably hot weather continued today for northern California, but more heat and stronger breezes are coming our way through early next week.
KHSL Severe
KHSL Radar
KHSL Temperatures

Community Events