Medicine recalls
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| The United States: Mylan initiates voluntary nationwide recall of three lots of Nizatidine Capsules, USP, due to the detection of trace amounts of NDMA (N-nitrosodimethylamine) impurity found in the active pharmaceutical ingredient manufactured by Solara Active Pharma Sciences Limited |
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The US Food and Drug Administration (FDA) announces that Mylan N.V. is conducting a voluntary nationwide recall, to the consumer level, of three lots of Nizatidine Capsules, USP (including the 150mg and 300mg strengths). While Mylan has not received any reports of adverse events related to these batches to date, this product is being voluntarily recalled due to detected trace amounts of an impurity N-nitrosodimethylamine (NDMA) contained in the active pharmaceutical ingredient (API) Nizatidine, USP, manufactured by Solara Active Pharma Sciences Limited. The affected products are:
- Nizatidine Capsules, USP 150mg (lot number: 3086746)
- Nizatidine Capsules, USP 300mg (lot number: 3082876)
- Nizatidine Capsules, USP 300mg (lot number: 3082877)
NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables. NDMA has been classified as a probable human carcinogen (a substance that could cause cancer) according to the International Agency for Research on Cancer (IARC).
The finished products are manufactured by Mylan Pharmaceuticals Inc. These batches were distributed nationwide to wholesalers, mail order pharmacies, retail pharmacies, and a distributor between Jun 2017 and Aug 2018.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-initiates-voluntary-nationwide-recall-three-lots-nizatidine-capsules-usp-due-detection-trace
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Thursday, Jan 9, 2020
Issued at HKT 16:00
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