It's the latest in a series of nationwide
recalls since late September for Ranitidine.
Author: Travis Pittman, TEGNA Published: 3:22 AM CST November
13, 2019 Updated: 4:24 AM CST November 13, 2019
For the third time in the past week, a recall
has been issued for the generic version of a popular heartburn and ulcer drug
that is best known as Zantac.
Amneal Pharmaceuticals on Tuesday voluntarily
recalled dozens of lots of Ranitidine Tablets, 150 mg and 300 mg, and
Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL.
The drugs may contain N-Nitrosodimethylamine
(NDMA) at amounts above levels established by the Food and Drug
Administration. NDMA is a nitrosamine. The FDA says nitrosamines can be
found naturally in water, meats, dairy products and vegetables, but NDMA is
also a probable human carcinogen.
This link of the recall notice
contains lists for both the product names and counts, but also
their lot numbers and expiration dates. Consumers who have it are advised to stop
using it and to call call Stericycle at 866-918-8768, Monday –
Friday, 8:00 am – 5:00 pm EST for more information.
Amneal says there have been no adverse effects
reported as a result of this recall. If an adverse reaction is experienced,
consumers are advised to call their doctor
This is the third recall for Ranitidine since
last Wednesday. Aurobindo Pharma USA issued a recall for
capsules and syrup on Nov. 6. American Health Packaging issued a recall last Friday for
Ranitidine Syrup which was distributed to wholesalers for use in hospital
settings.
There have been nine recalls for
Ranitidine since Sept. 23.
The FDA released a statement Nov. 1 that
states its testing has found levels of NDMA in ranitidine "are similar to
the levels you would expect to be exposed to if you ate common foods like
grilled or smoked meats." But, the agency says it still must test
ranitidine in the human body to fully understand if it forms NDMA.
The same impurity is one of three nitrosamines
that have been found in some blood pressure medications, leading to dozens of
recalls since July 2018.
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