Medicine recalls
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| The United States: Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Recall of Two Lots of Quinapril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, Due to the Detection of N-Nitroso Quinapril Impurity |
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The US Food and Drug Administration (FDA) announces that Aurobindo Pharma USA, Inc. has initiated a voluntary recall of two lots of Quinapril and Hydrochlorothiazide Tablets USP 20mg / 12.5mg (Lot number: QE2021005-A, QE2021010-A), to the consumer level from the US market due to presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Quinapril above the proposed interim limit.
Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.
To date, Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aurobindo-pharma-usa-inc-initiates-voluntary-nationwide-recall-two-2-lots-quinapril-and
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 4 Mar 2022, with the latest update posted on 18 Aug 2022.
Ends/Wednesday, Oct 26, 2022
Issued at HKT 19:00
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