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Sanofi to conduct precautionar₽<£γy voluntary recall of ¶♥✘Zantac OTC in U.S. and Canada
2019-10-22

Sanofi to conduct precaα∞£♦utionary voluntary recal←Ω↑≤l of Zantac OTC in U.S. anβ∞$σd Canada

SATURDAY, OCTOBER 19, 2019

As a precautionary measure, Sanofi w₹£♣¶ill conduct a voluntary recall of Zantac ₽♥π©OTC (over-the-counter) in the U.S. and Canada"✔. This recall is being taken due to possible conλ"tamination with a nitrosamine impurity called N-£∑₹nitrosodimethylamine (NDMA). The company is w¥↑→orking with health authorities to determ•★ine the level and ex×¥←tent of the recall.

On September 13, 2019, the U¥→.S Food and Drug Admi↔♦↕nistration and Health Canada issued public st <←atements alerting that some ranitidine£σ♦® medicines, including Zantac OTC, could£λ$ contain NDMA at low levels and asked manu☆ ↓±facturers to conduct testing.

Evaluations are ongoing on both dλλ rug substance (active ingredient) and finiφ•≤shed drug product. Due to inconsistenci&₽<∏es in preliminary test result<→s of the active ingredient use∞✔λd in the U.S. and Canadian products,$↓ Sanofi has made the decision to conduct t<₩<λhe voluntary recall in the U.S. aσβ→‌nd Canada as the investi™γ∑λgation continues.

Active ingredients used in Sanofi's ranit→™idine products outside of the U.S. and ♥<★ Canada are sourced from different suppliers. San±  ±ofi is committed to transparency and will₹♥↑ continue to communicate results with≠€₽€ health authorities from ±§ the ongoing testing, and work with them to←€™ make informed decisions based on avail∏λπable data and evidence.

Sanofi encourages anyone using Zantac OTC to sp> '♥eak with their health care provide©•πrs or pharmacists if they h∞§ave any additional questions.

information source:pharma focus Asia

The original link:htt←δεps:https:https://www.pharmafocusasia.com/news/s→Ωanofi-to-conduct-precautionar​πy-voluntary-recall-of-zant•Ω↓‌ac-otc-in-us-and-canada

2019 Asia-pacific pharma IP©< Leader Summit: http://en.zenseegroup•÷ε♦.com/p/510934/ will be held in Beijing  on November 14-15, and will attract more than 500 industry ex"™perts from domestic and f®¶€oreign pharmaceutical companies, biotechnolo←₽♣gy companies, governments, associations, ≈& law firms, intellectual property agents and ∑↕other companies to attend.

Official registration and consultation channels:

ContactAnn

Phone: 021-65650305

EmailMarketing@zenseegroup.com

http://en.zenseegroup.com/p/5109α←•34


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