Medicine recalls
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| The United States: Voluntary lot withdrawals of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) for increased reports of allergic/hypersensitivity reactions (Update) |
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The US Food and Drug Administration (FDA) announces that the following additional lots of immune globulin intravenous (IGIV) and immune globulin subcutaneous (IGSC) have been voluntarily withdrawn by the manufacturers as a precautionary measure, due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant. Hypersensitivity and anaphylactic/anaphylactoid reactions are a known risk with immune globulin products. The affected products with additional lots voluntarily withdrawn are:
- Gamunex-C (lot number: B23K037203, B21K039363, B01J100623, B03J077152, B03J079503, B23L053203; manufacturer: Grifols)
- Gammaked (lot number: B03J086043; manufacturer: Grifols for Kedrion) (lot number: B13K127733; manufacturer: Grifols)
- Alyglo (lot number: 394C24030; manufacturer: GC Biopharma Corp.)
- Yimmugo (lot number: C795145, C795165; manufacturer: Biotest AG)
IGIV and IGSC are used for replacement therapy in patients with primary humoral immunodeficiency.
Please refer to the following website in FDA for details:
http://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/voluntary-lot-withdrawals-immune-globulin-intravenous-igiv-and-immune-globulin-subcutaneous-igsc-0
In Hong Kong, Gamunex-C Solution for Infusion 10% 5g/50ml (HK-63147) is a pharmaceutical product registered by Luen Cheong Hong Ltd (LCH) and is a prescription-only medicine, while the remaining products in the above FDA announcement are not registered pharmaceutical products in Hong Kong. As confirmed by LCH, the affected lots of Gamunex-C Solution for Infusion 10% 5g/50ml have not been imported into Hong Kong. Related news was previously issued by FDA and Health Canada, and was posted on the Drug Office website since 4 Mar 2022, with the latest update posted on 25 Oct 2025.
Ends/Saturday, Aug 15, 2026
Issued at HKT 12:30
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