High blood pressure (hypertension) and congestive heart failure (CHF) drugs that contain the drug valsartan were recalled recently, but the recall was just expanded August 8, 2018.
In this latest update, the Food and Drug Administration (FDA) says it expanded the list of products affected under the recall and even some valsartan-containing products that are unaffected. The FDA announced that Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg shipped to hospitals and retails centers and for mail-order consumers. Camber is a New-Jersey company.
While the valsartan drugs may contain a dangerous impurity, you should not simply stop taking your hypertension or CHF drug containing valsartan. You must see your doctor first. Stopping these drugs abruptly can lead to serious complications and even death.
Valsartan-containing drugs have been recalled because they contain the impurity N-nitrosodimethylamine (NDMA) as an active pharmaceutical ingredient known as an API. According to the FDA, “Test results from Hetero Labs show the amount of NDMA found in its valsartan API exceeds acceptable levels; although it is generally lower than the amount discovered in the API manufactured by Zhejiang (China).”
NDMA is classified as a likely human carcinogen (cancer-causing substance), and NDMA was found in multiple batches of valsartan tables manufactured by Hetero Labs Limited.
Don’t Stop Taking This Drug
Unfortunately, the drugs that contain the possibly tainted NDMA cannot be stopped abruptly, so people who may be taking dangerous defective drugs have to see their doctor for guidance on what to take in place of valsartan. So, people may be taking a dangerous drug and it’s very dangerous to stop taking the drug—a huge problem for possibly millions of people.
Valsartan Tablets USP 40 mg (All lots 31722-745-30) Expires 7/2018 – 6/2020
Valsartan Tablets USP 80 mg (All lots 31722-746-90 ) Expires 7/2018 – 6/202
Valsartan Tablets USP 160 mg (All lots 31722-747-90) Expires 7/2018 – 6/2020
Valsartan Tablets USP 320 mg (All lots 31722-748-90) Expires 7/2018 – 6/2020
The expanded recall in August further includes:
- A-S Medication Solutions LLC
- Bryant Ranch Prepack Inc,
- Camber Pharmaceuticals, Inc.
- H J Harkins Company
- Northwind Pharmaceuticals
- NuCare Pharmaceuticals Inc.
- Prinston Pharmaceutical Inc. (labeled as Solco Healthcare LLC)
- Proficient Rx LP, Remedy Repack
- Teva Pharmaceuticals (labeled as Major Pharmaceuticals)
- Teva Pharmaceuticals USA (labeled as Actavis)
The FDA advises consumers to call 1-800-505-9291 Monday to Friday between 9:00 a.m. and 5:00 p.m. CST or email [email protected] with any questions or concerns.
If you have been harmed by a dangerous drug or some other defective product that was recalled, contact an experienced defective drug attorney.