Medicine recalls
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| The United States: Amneal Pharmaceuticals, LLC. issues voluntary nationwide recall of Nizatidine Oral Solution, 15 mg／ml, due to potential levels of N-nitrosodimethylamine (NDMA) impurity amounts above the levels established by FDA |
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The US Food and Drug Administration (FDA) announces that Amneal Pharmaceuticals, LLC, Bridgewater, New Jersey is voluntarily recalling three lots (lot number: 06598004A, 06599001A and 06599002A) of Nizatidine Oral Solution, 15 mg/ml (75 mg/5 ml), packaged in 480 ml bottles to the consumer level. Nizatidine Oral Solution is being recalled due to potential N-nitrosodimethylamine (NDMA) amounts exceeding the levels established by FDA.
NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables.
Amneal Pharmaceuticals, LLC has not received any reports of adverse events that have been confirmed to be directly related to this recall. Nizatidine Oral Solution manufactured by Amneal, is a prescription oral product used for the short-term treatment and maintenance therapy of ulcers and for the treatment of esophagitis and associated heartburn due to gastroesophageal reflux disease (GERD).
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-voluntary-nationwide-recall-nizatidine-oral-solution-15-mgml-due
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Thursday, Apr 16, 2020
Issued at HKT 15:00
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