Valsartan and Valsartan Hydrochlorothiazide (HCTZ)
As of July 13th, the U.S. Food and Drug Administration (FDA) is alerting health care professionals and patients of a voluntary recall of several drug products containing the active ingredient Valsartan, used to treat high blood pressure and heart failure. This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. However, not all products containing Valsartan are being recalled.
The FDA’s review is ongoing and has included investigating the levels of NDMA in the recalled products, assessing the possible effect on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company.
Information for Patients and Health Care Professionals
- 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.
- To determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.
- If a patient is taking one of the recalled medicines listed below, they should follow the recall instructions provided by the specific company. This information will be posted to the FDA’s website: www.fda.gov.
- 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.
The companies listed below are recalling all lots of non-expired products that contain the ingredient Valsartan supplied to them by Zhejiang Huahai Pharmaceuticals, Linhai, China. Not all Valsartan-containing medicines distributed in the United States have Valsartan active pharmaceutical ingredient (API) supplied by this specific company. Zhejiang Huahai has stopped distributing its Valsartan API and the FDA is working with the affected companies to reduce or eliminate the Valsartan API impurity from future products.
||Teva Pharmaceuticals Industries Ltd.
||Teva Pharmaceuticals Industries Ltd.
The FDA will continue to investigate this issue and provide additional information when it becomes available. The agency encourages patients and health care professionals to report any adverse reaction to the FDA’s MedWatch program.
Fluticasone Nasal Spray – Apotex Corp.
On May 31, 2018 the U.S. Food and Drug Administration (FDA) announced that Apotex Corp. initiated a voluntary recall of one lot of Fluticasone Nasal Spray. This recall is on the following lot: NJ4501. This recall has been initiated as a precautionary measure based on a customer complaint that a bottle had been found to contain small glass particles.
There is a potential for patients to be exposed to the glass particles and mechanical irritation cannot be ruled out. Local trauma to the nasal mucosa might occur with the use of the defective product. To date, Apotex Corp. has not received any reports of adverse events related to recall. Fluticasone Propionate Nasal Spray is indicated for the treatment of seasonal and perennial allergic rhinitis and for the management of sinus pain and pressure associated with allergic rhinitis in patients 4 to 17 years of age. The affected Fluticasone Propionate Nasal Spray can be identified by the information in the table below and on the product label:
50 mcg per spray
120 Metered Sprays
Carton containing 1 Bottle of 50 mcg per spray 120 Metered Sprays
What You Should Do:
- If you need help to see if your drug has been recalled, call the pharmacy that filled it.
- If you have Fluticasone Nasal Spray from the recalled lot, stop use and contact Apotex Corp. by phone at 1-800-706-5575, 8:30 am to 5:00 pm EST, Monday through Friday.
- If you have medical questions, contact your doctor for guidance.