Posted from: Thursday, July 19, 2018 - 10:03 AM - Present

Drug Recall: Select Products Containing Valsartan Voluntarily Recalled

On July 13, 2018, the U.S. Food and Drug Administration (FDA) announced a voluntary recall of select medications that contain the active ingredient valsartan. The affected products are manufactured by Major Pharmaceuticals, Prinston Pharmaceutical (doing business as Solco Healthcare), and Teva Pharmaceuticals. All affected products contain an ingredient sourced from a single supplier, Zhejiang Huahai Pharmaceutical.

According to the FDA, affected products may contain an impurity detected by Huahai Pharmaceutical and through FDA testing. The impurity was unexpected, and may be due to changes in Huahai’s manufacturing process. Huahai has halted distribution of the ingredient. The impurity is caused by N-nitrosodimethylamine (NDMA), which is considered a probable human carcinogen, a substance that may cause cancer. The FDA is currently conducting further investigation to determine the levels of NDMA present in affected products and its potential effects.

The investigation into affected products is currently ongoing. Additional manufacturers and medications may be impacted. BeneCard PBF will provide updates as they become available.

Because quantities of unaffected valsartan are limited, members should contact their prescriber for assistance in switching to an alternative angiotensin receptor blocker. Valsartan is used to treat serious medical conditions, and the FDA advises that patients should continue their current medication until provided with a replacement product.

 

Benecard Central Fill is notifying members of the recall. The following products are currently affected:

Medicine

Company

Valsartan

Major Pharmaceuticals

Valsartan

Solco Healthcare / Prinston Pharmaceutical

Valsartan

Teva Pharmaceuticals Industries Ltd.

Valsartan/Hydrochlorothiazide (HCTZ)

Solco Healthcare / Prinston Pharmaceutical

Valsartan/Hydrochlorothiazide (HCTZ)

Teva Pharmaceuticals Industries Ltd.

 

Patients should check for the drug name and company name on the label of their prescription bottle to determine if it has been recalled. For patients who fill their medication with Benecard Central Fill, this information is located on the bottom right corner of the label. If patients have received their medication from another pharmacy, and the information is not on the bottle, they should contact the pharmacy that dispensed the medicine.

Further information is available at: https://www.fda.gov/Drugs/DrugSafety/DrugRecalls/default.htm and

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM613532.htm.

 

Adverse events that may be related to the use of this product may also be reported to the United States Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:

Online: www.fda.gov/medwatch/report.htm

Use the postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm.

Mail the form to: MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787    Fax the form to: 1-800-FDA-0178

Last Updated Friday, August 17, 2018 - 07:50 PM.