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| The United States: Voluntary lot withdrawal of Allergenic Extract – Pecan nut (Carya illinoinensis) – for diagnostic use only, manufactured by ALK-Abelló, Inc. for increased reports of false negative test results (English only) |
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The US Food and Drug Administration (FDA) announces that one lot (Lot Number: 0003963971) of Allergenic Extract – Pecan nut (Carya illinoinensis) – for diagnostic use only, manufactured by ALK-Abelló, Inc. has been voluntarily withdrawn by the manufacturer due to increased postmarketing adverse event reporting of false negative skin test results, with one case reported of life-threatening anaphylaxis from subsequent pecan nut exposure.
Please refer to the following website in FDA for details:http://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/voluntary-lot-withdrawal-allergenic-extract-pecan-nut-carya-illinoinensis-diagnostic-use-only
In Hong Kong, the above product is not a registered pharmaceutical product.
Related news was previously issued by Health Canada and was posted on the Drug Office website on 9 Sep 2023.
On 5 Sep 2023, the Department of Health endorsed Ksena Healthcare Limited (Ksena), to recall the above-mentioned affected batch of skin test reagent for allergy to pecan nut due to potential quality issue. The product was imported for the treatment of particular patient by registered medical practitioner through Ksena. A recall statement was posted on the Drug Office website on the same date.
Ends/ Saturday, Sep 23, 2023
Issued at HKT 12:00
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