Pharmacy Services Alerts
Valsartan and Valsartan/Hydrochlorothiazide Recall - Raw Ingredient May Contain a Potential Carcinogen - UPDATED
Sep 14, 2018 9:32 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. Several repackagers have also been found to be 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 and Camber Pharmaceuticals 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.
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 Teva Medical Information by phone at 888-838-2872 or by email at firstname.lastname@example.org; 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 email@example.com; Torrent Medical Information by phone at 800-912-9561 or by email at firstname.lastname@example.org. 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 – updated August 8, 2018:
- Affected by recall:
- NOT affected by recall:
- Affected by recall:
- MedWatch Safety Alert – updated August 9, 2018:
- FDA Press release – July 13, 2018:
- Camber Pharmaceuticals, Inc. press release– August 8, 2018
- Major Pharmaceuticals press release – July 13, 2018
- Solco Pharmaceuticals (Prinston Pharmaceutical) press release – July 17, 2018
- Teva Pharmaceuticals (Actavis) press release – July 17, 2018
- Torrent Pharmaceuticals Limited press release – August 17, 2018
- FDA Press release – September 13, 2018