Blood Pressure Drugs Recalled Due to Unsafe Impurities
In July 2018, the United States Food and Drug Administration issued a statement to healthcare providers alerting them of a voluntary recall of a group of pharmaceuticals containing the API (active pharmaceutical ingredient) valsartan. Not all pharmaceuticals containing valsartan are affected by the recall, but many are.
What is valsartan and NDMA?
Valsartan is an API (active pharmaceutical ingredient) in several medications used to treat serious conditions like high blood pressure and heart failure. Recent laboratory tests of these medications revealed the presence of an impurity called N-nitrosodimethylamine (NDMA). NDMA is classified by the FDA as a possible human carcinogen, which means it has the potential to cause cancer. Manufacturers of these medications issued a voluntary recall when these impurities were found in quantities that far surpassed the threshold the FDA considers safe.
Since the initial recall notice in early July 2018, other manufacturers have also discovered the presence of NDMA and have joined the voluntary recall at the behest of the FDA. (You can read the latest updates from the FDA here.)
Which manufacturers and drugs are affected by these recalls?
It is important to understand that not all products that contain valsartan are affected by the recall. Therefore, all patients should inspect their prescription bottles to determine the manufacturer of their particular medication and cross reference the list of affected medications provided by the FDA.
As of August 8, 2018, the list of known manufacturers with pharmaceuticals containing NDMA-tainted valsartan includes:
- Teva Pharmaceuticals labeled as Major Pharmaceuticals
- Prinston Pharmaceutical Inc. labeled as Solco Healthcare LLC
- Teva Pharmaceuticals USA labeled as Actavis
- Remedy Repack
- A-S Medication Solutions LLC
- Bryant Ranch Prepack Inc.
- H J Harkins Company Inc. dba Pharma Pac
- Northwind Pharmaceuticals
- Camber Pharmaceuticals, Inc.
- NuCare Pharmaceuticals Inc.
On August 22, 2018, the FDA also added all lots of valsartan medications from Torrent Pharmaceuticals Limited to the list of recalled products. You can read more about these additional recalls at the FDA’s link.
- Torrent Pharmaceuticals Limited
On August 27, 2018, the FDA again expanded the list of medications affected by NMDA impurities. The most current list of affected valsartan medications can be found here. CNN reported that the FDA also published a list of valsartan medications that are NOT currently affected by NDMA.
What should I do if my valsartan medication is affected by the NDMA impurities?
Because valsartan is used in medicines to treat serious medical conditions, patients taking the recalled valsartan-containing medicines should continue taking their medicine until they have a replacement product. According to the FDA, patients should also contact their health care professional (the pharmacist who dispensed the medication or doctor who prescribed the medication) if their medicine is included in this recall to discuss their treatment, which may include another valsartan product not affected by this recall or an alternative treatment option.
Now Accepting Valsartan Cases
The Justice Attorneys at Aylstock, Witkin, Kreis & Overholtz, PLLC are investigating claims against the manufacturers of valsartan and associated drugs. Contact our valsartan attorneys today at (844) 794-7402 for a free consultation. There is never a fee unless we recover for you.
Bibliography and References
Free Case EvaluationYou will never be charged a fee unless a recovery is made for you.
Aylstock, Witkin, Kreis & Overholtz is a national law firm geared towards protecting the rights of consumers who are seriously injured as a result of defective products, defective medical devices, accidents, or other negligent behavior.
The lawyers representing Aylstock, Witkin, Kreis & Overholtz are licensed to practice law in fourteen states (FL, AL, MS, LA, TX, CO, MN, PA, NY, NJ, NV, MT, WA, OH), with associated counsel in all remaining states. Aylstock, Witkin, Kreis & Overholtz is a national leader in fighting for consumer justice.
Aylstock, Witkin, Kreis & Overholtz
17 E. Main Street, Suite 200
Pensacola, Florida 32502
Phone: (850) 202-1010
Toll Free: (844) 794-7402
Fax: (850) 916-7449
Post Office Box 12630
Pensacola, Florida 32591