Drug Safety Alerts

Valsartan Tablets Voluntary recall

7/13/18

For the most current information from FDA, please visit FDA’s website at: www.fda.gov/drugs/drugsafety/ucm613916.htm

UPDATE (08/21/18):

Torrent Pharmaceuticals Limited expanded it’s recall to include Amlodipine/Valsartan tablets and Valsartan tablets. They also expanded the previous recall of Valsartan/Amlodipine/HCTZ tablets to include all lots.

UPDATE (08/17/18):

Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.

To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall.

Valsartan is used to control high blood pressure and for the treatment of heart failure. In combination with amlodipine plus hydrochlorothiazide, it is used to control high blood pressure. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on valsartan should continue taking their medication, as the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment.

UPDATE (08/14/18):

On August 14, 2018, AvKare announced a patient-level recall of all valsartan tablets that were previously recalled by Camber and packaged under the AvKare/AvPak label

UPDATE (08/09/18):

On August 9, 2018, Camber Pharmaceuticals, Inc. announced a CONSUMER LEVEL RECALL of Valsartan tablets. This recall of multiple batches of Valsartan Tablets was prompted due to the detection of trace amounts of N-Nitrosodimethylamine (NDMA), a possible process impurity or contaminant in an active pharmaceutical ingredient, (API manufacturer).This recall is being carried out to the CONSUMER LEVEL and is for all lot numbers.

UPDATE (08/02/18):

FDA continues to evaluate valsartan-containing products and has updated the list of products included in the recall and the list of products not included in the recall. In addition to updating the lists, FDA revised information related to A-S Medication on the list of products included in the recall. The agency will continue to provide information when it becomes available.

FDA is working with drug manufacturers to ensure future valsartan active pharmaceutical ingredients (APIs) are not at risk of NDMA formation. The agency reminds manufacturers to thoroughly evaluate their API manufacturing processes, and changes to those processes, to detect any unsafe impurities. If a manufacturer detects new or higher levels of impurity, they should take action to prevent changes to the product’s safety profile. 

UPDATE (07/27/18):

On July 27, 2018, FDA posted updated information regarding the valsartan recalls.

FDA has product recall information from two additional repackagers of valsartan-containing products made by Teva Pharmaceuticals and Prinston Pharmaceuticals Inc./Solco Healthcare and the agency has added them to the recalled products list. These companies, A-S Medication and RemedyRepack, may also distribute valsartan products not affected by the recall. The agency is confirming this information and will provide an update once it is available.

In addition, FDA has indicated that the following additional repackagers are recalling or are expected to recall valsartan-containing products. FDA is working to gather product recall information from these companies and has removed them from the list of products that are not impacted by this recall:

• Bryant Ranch Prepack Inc.

• H. J. Harkins Company Inc. (this company was not originally included on either list)

• Lake Erie Medical, doing business as Quality Care Products LLC

• NuCare Pharmaceuticals Inc.

• Northwind Pharmaceuticals

• Proficient Rx

It is possible that not all valsartan-containing products repackaged by these companies are impacted by the recall. 

On July 13, 2018, FDA alerted 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. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.

The companies impacted 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.

• On July 13, 2018, Major Pharmaceuticals issued a nationwide voluntary recall of all lots within expiry of Valsartan which were supplied by Teva Pharmaceuticals and labeled as Major Pharmaceuticals. This recall was initially issued to the pharmacy level only, but upon further discussion we now understand that it will be elevated to patient-level.

• On July 17, 2018, Solco Healthcare issued a patient-level recall of all valsartan and valsartan/hydrochlorothiazide tablets.

• On July 18, 2018, Teva Pharmaceuticals announced a patient-level recall of all valsartan and valsartan/hydrochlorothiazide tablets distributed under the Actavis label.

• On July 18, 2018, AvKare announced a patient-level recall of all valsartan/hydrochlorothiazide tablets that were previously recalled by Teva/Actavis and packaged under the AvKare label.

A complete list of the affected products is provided here:

CVS Caremark Response:

Please note: Due to this recall, there is little replacement product containing valsartan available at this time and we anticipate disruptions in supply for some time. However, we do have alternate medications available in this drug class such as losartan. Because valsartan is used in medicines to treat serious medical conditions, the United States Food and Drug Administration (FDA) recommends that patients should not stop their medicine until they receive replacement product or an alternate medicine to treat their condition. CVS Caremark is in the process of contacting patients and prescribers to advise them of this recall. We are contacting prescribers whose patients are taking valsartan tablets to obtain prescriptions for an alternate medicine.

For more information, please call the FDA at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm

For contact information for the drug manufacturers involved, please see below: