Valsartan-Containing Products Recalled By Some Manufacturers

Note: Check back regularly for the most up-to-date information on this recall

On July 13th, the FDA announced a recall of medications containing Valsartan, a generic medication used to treat high blood pressure and heart failure from multiple manufacturers due to an impurity (NDMA) detected in the recalled products. On November 21st, the FDA announced an additional recall of medications containing Valsartan that were manufactured by Mylan, due to trace amounts of a different impurity (NDEA) detected in the recalled products. The Food and Drug Administration has stated that because Valsartan is used to treat serious medical conditions, patients taking a recalled Valsartan-containing medication should continue taking their medicine until they have an alternative therapy or new supply.

FDA current findings on the impurity NDMA:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm619024.htm?utm_campaign=Statement%20from%20FDA%20Commissioner%20Scott%20Gottlieb%2C%20M.D.%2C%20and%20Janet%20Woodcock%2C%20M.D.&utm_medium=email&utm_source=Eloqua

FDA statement on the impurity NDEA

NDEA 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 according to the International Agency for Research on Cancer (IARC).

Where can I find the manufacturer name on my label?

The manufacturer information is located on the right-hand side and towards the bottom of the bottle label, as shown below.

Which Valsartan containing products are affected by the recall?

• Valsartan with Hydrochlorothiazide manufactured by Alembic is NOT affected by this recall.
• Solco is the only manufacturer currently providing customer reimbursement. If the manufacture on your label is not Solco, we recommend that you check this page periodically in the event that other manufacturers announce the availability of customer reimbursement in the future.
• Additional information about the recall is available on the FDA website:
  
  General Information: https://www.fda.gov/drugs/drugsafety/ucm613916.htm
  • Solco Healthcare recall information - https://www.fda.gov/Safety/Recalls/ucm613504.htm
    For questions about returns/reimbursement, please contact Solco's consumer line at 888-679-5120. Solco customer service will require the NDC number of the product dispensed and a pharmacy receipt with the date of purchase. The NDC number can be located on the first page of your original invoice, next to the Rx number. Solco NDC numbers impacted by the recall are also listed below:
    

    Drug	Strength	NDC number
    VALSARTAN TABS	160MG	43547036909
    VALSARTAN TABS	320MG	43547037009
    VALSARTAN TABS	40MG	43547036703
    VALSARTAN TABS	80MG	43547036809
    VALSARTAN/HCTZ TABS	80/12.5	43547031109
    VALSARTAN/HCTZ TABS	160/12H	43547031209
    VALSARTAN/HCTZ TABS	160/25	43547031309
    VALSARTAN/HCTZ TABS	320/25	43547031509
    VALSARTAN/HCTZ TABS	320/12H	43547031409

  • Major Pharmaceuticals recall information - https://www.fda.gov/Safety/Recalls/ucm613625.htm
  • Teva (Actavis/AvKARE/Watson) Pharmaceuticals recall information - https://www.fda.gov/Safety/Recalls/ucm613729.htm
    A separate recall was issued by Teva on November 26th for all lots of Valsartan/Amlodipine tablets and all lots of Amlodipine/Valsartan/Hydrochlorothiazide tablets within their expiration dates due to the presence of the impurity NDEA.
    
    https://www.fda.gov/Safety/Recalls/ucm626802.htm
    
    It is important to note that your home delivery pharmacy will NOT be accepting returns or providing credit for these recalled products. To request a return, contact Teva's recall processor Inmar at 877-297-8404 (M-F 9am to 5pm ET)
  • Camber Pharmaceuticals recall information - https://www.fda.gov/Safety/Recalls/ucm616405.htm It is important to note that your home delivery pharmacy will NOT be accepting returns or providing credit for this recalled product. To request a return kit for your recalled product, please contact Qualanex (the recall coordinator for Camber) by email recall@qualanex.com or by calling 800-505-9291 toll free and follow the instructions below:
    a. Explain that your pharmacy is not accepting returns of the recalled product
    b. Provide the product NDC number (located on the first page of your original invoice, next to the Rx number) or a description of the tablet.
    c. You will be sent a return kit that includes a letter response form for you to complete and mail back in (allow two weeks for the return kit to arrive after requested).
  • Torrent Pharmaceuticals recall information - https://www.fda.gov/Safety/Recalls/ucm617821.htm
    All batches/lots of Valsartan containing products manufactured by Torrent Pharmaceuticals (Valsartan Tablets, Amlodipine/Valsartan Tablets and Amlodipine/Valsartan/HCTZ Tablets) are impacted by the recall. It is important to note that your home delivery pharmacy will NOT be accepting returns or providing credit for this recalled product. For questions regarding the return of recalled medication, please contact Qualanex (the recall coordinator for Torrent) at 1-800-505-9291 (live calls received 8am to 5:30 pm Eastern Time)
  • Mylan Pharmaceuticals recall information - http://investor.mylan.com/news-releases/news-release-details/mylan-expands-its-voluntary-nationwide-recall-valsartan-tablets
    Mylan has recalled all lots of Valsartan-containing products (Valsartan, Valsartan/Amlodipine, and Valsartan/Hydrochlorothiazide), that are within their expiration date.
    
    Patients that are in possession of recalled product should contact Stericycle at 1-888-406-9305 for the return of the recalled product. Stericycle normal business hours are Monday through Friday 8 a.m. to 5 p.m. EST.
  • Aurobindo Pharma USA Information
    https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aurobindo-pharma-usa-inc-initiates-voluntary-nationwide-consumer-level-recall-80-lots-amlodipine
    
    https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aurobindopharma-usa-inc-initiates-voluntary-nationwide-consumer-level-recall-expansion-38-lots
    
    Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 80 lots of Amlodipine/Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP to the consumer level due to the detection of trace amounts of N-nitrosodiethylamine (NDEA). Express Scripts will mail letters to patients who have received medication impacted by the recall.
    
    An additional 38 lots were recalled on 2/28/19 due to the detection of trace amounts of N-nitrosodiethylamine (NDEA), an impurity also found naturally in certain foods, drinking water and air pollution.
    
    It is important to note that your home delivery pharmacy will NOT be accepting returns or providing credit for this recalled product. For any general questions regarding the return of this product please contact Inmar\CLS-Medturn at 1-877-208-2407 or email rxrecalls@inmar.com (live calls received 9 am -5:00 pm Eastern Time).

What do I need to know?

• Because multiple manufacturers are impacted by this recall, there is limited supply of Valsartan containing products in the market place, specifically single ingredient Valsartan drug products. If you are taking single-ingredient Valsartan, it is very important that you speak with your prescriber about an alternative therapy and send in a new prescription for that new drug therapy. Refilling your existing prescription may result in a delay in processing and receipt of a different medication than originally prescribed.
• The Food and Drug Administration has stated that patients who have the recalled medicine should continue taking it until they have a new supply unless otherwise directed by their healthcare provider, as the risk of harm to the your health may be higher if the treatment is stopped immediately without any alternative treatment.
  • Please consult with your prescriber for guidance on continuing to take this medication or if you should obtain a new prescription for an alternative therapy.
  • If you and your prescriber decide you should continue to take the medication on hand, your next fill will be processed using medication that is not part of any existing recall.
  • If you choose to stay on this therapy but need to obtain a fresh supply and it is not time for your next refill, please call us at the toll free number on your prescription bottle to request an early refill. Your order will be filled with medication that is not part of any existing recall.

Why was this medication recalled?

• This voluntary recall is being issued by the manufacturers working with the FDA because an impurity, N-nitrosodimethylamine (NDMA) or N-nitrosodiethylamine (NDEA), was detected in the recalled products. However, not all products containing Valsartan are being recalled.
• Any suspected adverse events that may be related to the use of these products should be reported to your doctor. You can also report adverse events that may be related to this recall to FDA's Med Watch Program either online, by regular mail or by fax.
  • Online: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home
  • Regular Mail: Use postage-paid, pre-addressed Form FDA 3500B available at: http://www.fda.gov/MedWatch/getforms.htm. Mail to the address on the pre-addressed form.
  • Fax: 1-800-332-0178 (toll free)