Select Valsartan-Containing Products Voluntarily Recalled
July 13, 2018 – Manufacturers have voluntarily recalled several products that contain the active ingredient valsartan upon learning that they may be contaminated with a probable human carcinogen (cancer-causing agent). Not all valsartan products are affected. Only products manufactured with ingredients sourced from Zhejiang Huahai Pharmaceutical have been recalled.
Huahai identified N-nitrosodimethylamine (NDMA) contamination in its valsartan active ingredient, which is supplied to a number of drug manufacturers, and voluntarily notified the European Medicines Agency (EMA). This led to a recall of valsartan-containing products in the European Union on July 5, 2018. Countries in Asia have also been affected. The contamination of Huahai’s valsartan active ingredient is believed to be due to changes in the manufacturing process, and may have been present as early as 2014.
Originally, products distributed in the United States were not believed to be impacted. However, after further review and testing, the U.S. FDA announced a voluntary recall on July 13, 2018, of valsartan and valsartan/hydrochlorothiazide (HCTZ) from Prinston Pharmaceuticals (doing business as Solco Healthcare) and Teva Pharmaceuticals. The recall also includes valsartan from Major Pharmaceuticals.
The FDA is currently working with affected manufacturers to address the impurity in their products, and Huahai has halted distribution of the contaminated ingredient. In addition, the FDA has tasked its drug shortages team with ensuring the United States can maintain an adequate supply of valsartan products not affected by the recall. Supplies of unaffected valsartan products may be limited, and patients should consider asking their doctors about switching to an alternative angiotensin receptor blocker.
BeneCard PBF and its mail order and specialty pharmacy, Benecard Central Fill, have notified affected members of the recall.
Any adverse effects associated with the recalled products should be reported to the FDA’s MedWatch program. Additional information can be found at the following websites:
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.