Sandoz Voluntarily Recalling Ranitidine Hydrochloride Capsules in U.S.
September 24 2019 - 12:14PM
Dow Jones News
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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