By Michael Dabaie

 

Novartis AG's (NVS) Sandoz Inc. said it is voluntarily recalling ranitidine hydrochloride capsules in the U.S.

Sandoz said it is recalling all quantities and lots within expiry because of confirmed contamination with N-Nitrosodimethylamine, or NDMA, above levels established by the U.S. Food and Drug Administration in batches of Sandoz Ranitidine Hydrochloride Capsules. NDMA is classified as a probable human carcinogen.

Sandoz said it hasn't received any reports of adverse events related to use of the product. Sandoz said late Monday it was notifying distributors and customers via overnight mail and its web site, and will arrange for return of all recalled products.

The FDA earlier this month said it learned of NDMA found at low levels in some versions of Zantac, or ranitidine.

Sandoz said last week that it halted distribution of ranitidine as a precaution.

 

Write to Michael Dabaie at michael.dabaie@wsj.com

 

(END) Dow Jones Newswires

September 24, 2019 11:59 ET (15:59 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.
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