Medicine recalls
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| The United States: AuroMedics Pharma LLC issues voluntary nationwide recall of Pantoprazole Sodium for Injection 40mg Per Vial due to presence of glass particles in the vial |
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The US Food and Drug Administration (FDA) announces that East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling one lot of Pantoprazole Sodium for Injection 40 mg per vial, to the hospital level. The product was found to contain glass particles in the vial. This problem was discovered as a result of a product complaint in which the contents of one vial from one batch was found to contain a piece of glass. The affected Pantoprazole Sodium for Injection lot being recalled is CPO170035, EXP. May 2019, and is packaged in a carton containing 10 vials.
The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening. To date, AuroMedics Pharma LLC has not received reports of any adverse events or identifiable safety concerns attributed to this recall.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm589694.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Wednesday, Dec 20, 2017
Issued at HKT 16:00
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