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 |
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The US Food and Drug Administration (FDA) announces that the following lots of immune globulin intravenous (IGIV) and immune globulin subcutaneous (IGSC) have been voluntarily withdrawn by the manufacturers as a precautionary measure, due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically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 are:
- Xembify (lot number: B01J108133, B01J107803; manufacturer: Grifols)
- Bivigam (lot number: 321524, 321724; manufacturer: ADMA Biologics)
- Panzyga (lot number: L319C8261; manufacturer: Octapharma)
- Gamunex-C (lot number: B01J112733; manufacturer: Grifols)
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). The product is a prescription-only medicine. As confirmed by LCH, the affected lot has not been imported into Hong Kong. Xembify, Bivigam and Panzyga are not registered pharmaceutical products in Hong Kong. Related news was previously issued by FDA, and was posted on the Drug Office website on 4 Mar 2022.
Ends/Tuesday, Mar 11, 2025
Issued at HKT 16:30
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