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| The United States: Fresenius Kabi issues voluntary recall of Sodium Acetate Injection, USP due to the presence of particulate matter (English Only) |
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The US Food and Drug Administration (FDA) announces that Fresenius Kabi USA is voluntarily recalling 7 lots of Sodium Acetate Injection, USP, 400 mEq/100 ml (4 mEq/ml), 100 ml fill in a 100 ml vial (lot number: 6124193, 6124196, 6124226, 6124532, 6125333, 6125678, 6126846) to the user level due to the presence of particulate matter found in reserve and/or stability sample vials. Microscopic and elemental analyses determined the presence of particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.
The administration of an injectable product that contains particulate matter may result in local irritation or swelling or infection in response to the foreign material. If the particulate matter reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. To date, no adverse event reports have been received for these recalled lots, which were produced and sold in 2020 and 2021.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-recall-sodium-acetate-injection-usp-due-presence-particulate-matter
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Tuesday, Mar 8, 2022
Issued at HKT 13:00
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