Teva Pharmaceuticals Valsartan Recall [US]


US FlagUS/Silver Spring: Teva Pharmaceuticals Valsartan Recall [US]Teva Pharmaceuticals USA, a Parsippany-Troy Hills, New Jersey establishment, recalls all current batch/lots of Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets due to suspected contamination N-nitroso-diethylamine (“NDEA”) a probable human carcinogen., all serious health and safety hazards.

FDA: http://ht.ly/YzxN30mRMeY

Direct link: https://www.fda.gov/Safety/Recalls/ucm626802.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following drugs are subject to this recall:

The complete list of drugs, batch/lots and is available on the Web site identified above.

Please consult the photograph above for details of the food’s packaging, design and retail presentation. Additional images of the recalled drug products can be found on the Web site above.

==> No barcodes, UPCs, item numbers or other identification numbers were listed with this recall notification.

According to the FDA, Teva Pharmaceuticals has recalled all current lots of Amlodipine / Valsartan combination Tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination Tablets (please see Web site) due to an impurity detected above specification limits in an active pharmaceutical ingredient (“API”) manufactured by Mylan India. The impurity found in Mylan’s Valsartan API is known as N-nitroso-diethylamine (“NDEA”), which has been classified as a probable human Carcinogen.

Amlodipine/Valsartan combination tablets and Amlodipine/Valsartan/Hydrochlorothiazide combination tablets are used for the treatment of high blood pressure.

This issue is not limited to Valsartan medicines manufactured and distributed by Teva. Some Valsartan-containing products manufactured and distributed by other pharmaceutical companies using the same API supplier may also be affected.

==> Never stop taking your prescription medications, including Amlodipine / Valsartan combination Tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination Tablets, without the knowledge and approval of your personal physician or other MD familiar with your medical history, current health status and other drugs, medications and supplements you may be consuming. Failure to do so, may result in a serious drug interaction, side effect, complication, personal injury and/or death.

If you have any question about this recall, please contact Teva Pharmaceuticals USA toll-free at 1-888-838-2872, option 3, then, option 4. Live calls are received Monday to Friday, 9:00 AM to 5:00 PM, Eastern Time with voicemail outside of these hours or by e-mail druginfo@tevapharm.com.

==> To see other recalls and notifications caused by contaminated, adulterated or mislabeled drug, please search for “drug” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by Teva Pharmaceuticals USA, please search for “Teva” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 10898-2018
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
==> http://wp.me/P2bVty-2
Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe Meat, Poultry or Processed Egg product you purchased in the US [external: new window opens]:
==> https://ccms.fsis.usda.gov/
==> You can also all the toll-free USDA Meat and Poultry Hotline at 1-888-674-6854
Search for a recalled product on the USDA Web archive [external: new window opens]:
==> https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive

We welcome your feedback:
Want to e-mail or share this recall?
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E. & O. E.

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