Pharmacy Services Alerts
Valsartan and Valsartan-containing Products Recall - Raw Ingredient May Contain a Potential Carcinogen - UPDATED
Apr 5, 2019 8:01 AM
In July 2018, Major, Solco, and Teva voluntarily recalled medications containing valsartan as the active ingredient. More manufacturers have recently recalled their valsartan products. Mylan has recalled all lots of valsartan-containing products and Aurobindo Pharma USA has recalled 80 lots of valsartan-containing products. In March, 2019, Aurobindo Pharma USA expanded their recall to include 38 additional lots of valsartan-containing products distributed under the Aurobindo Pharma USA and Acetris Health labels. Several repackagers have also been affected and have recalled their products. A substance known as N-nitrosodimethylamine (NDMA) was found in the active pharmaceutical ingredient made by Zhejiang Huahai Pharmaceuticals in China, Camber Pharmaceuticals in India, and Mylan Laboratories Limited in India. This substance is classified as a probable human carcinogen. Another suspected carcinogen, N-nitrosodiethylamine (NDEA), has also been found in certain lots of active pharmaceutical ingredient made by Zhejiang Huahai Pharmaceuticals. Valsartan is a medication used to treat hypertension and certain heart conditions such as heart failure. No adverse events have been reported at this time.
FDA continues to update and post lists of both affected and unaffected valsartan products. FDA is also working to determine if other manufacturers of valsartan and related medications could be impacted by NDMA and NDEA impurities. In April 2019, the FDA published a list of currently marketed ARB presentations and their nitrosamine assessment. The FDA plans to continually update this list as new information becomes available. The list can be found at https://www.fda.gov/drugs/drug-safety-and-availability/fdas-assessment-currently-marketed-arb-drug-products.
Pharmacies are to quarantine all affected presentations and return recalled product per the instructions of the individual suppliers. Patients are to continue on their medication until they can get a replacement from the pharmacy or have discussed other options with their healthcare providers. Patients with questions regarding this recall may contact Aurobindo Pharma USA by phone at 866-850-2876 (option 2) or by email at firstname.lastname@example.org; Teva Medical Information by phone at 888-838-2872 or by email at email@example.com; Solco by phone at 888-679-5120; and Major Pharmaceutical Support at 800-616-2471; Camber Pharmaceuticals Qualanex Customer Service by phone at 800-505-9291 or by email at firstname.lastname@example.org; Torrent Medical Information by phone at 800-912-9561 or by email at email@example.com; Mylan Medical Information by phone at 888-406-9305. Consumers should report any adverse reactions experienced from this product to their provider and the FDA MedWatch Adverse Event Reporting program.
Additional Information including affected bottles and lot numbers are available in the following links:
- Valsartan product lists – as of March 19, 2019:
- List of recalled angiotensin II receptor blockers (ARBs)
- American Health Packaging Press Release – March 7, 2019:
- Aurobindo Press Release – March 1, 2019
- Aurobindo Press Release – December 31, 2018
- Mylan Press Release – December 4, 2018:
- Teva Pharmaceuticals (Actavis) press release – November 27, 2018
- Torrent Pharmaceuticals Limited press release – August 17, 2018
- Mylan press release – November 20, 2018
- Teva press release – July 17, 2018
- Prinston Pharmaceutical press release – July 16, 2018
- Major Pharmaceuticals press release – July 13, 2018
- FDA overview of angiotensin II receptor blocker (ARB) recalls
- FDA updates on angiotensin II receptor blocker (ARB) recalls
- FDA Q&A on impurities found in ARB products