Medicine recalls
|
| |
| The United States: Voluntary lot withdrawals of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) for increased reports of allergic/hypersensitivity reactions (Update) |
| |
The US Food and Drug Administration (FDA) announces that additional lots of immune globulin intravenous (IGIV) and immune globulin subcutaneous (IGSC) have been voluntarily withdrawn by the manufacturers as a precautionary measure, due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically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 The affected products with additional lots voluntarily withdrawn are:
- Alyglo (lot number: 394C25018, 394C25019, 394C25020; manufacturer: GC Biopharma Corp.)
- Yimmugo (lot number: C795314; manufacturer: Biotest AG)
The products 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/calendar-year-2026-voluntary-lot-withdrawals-immune-globulin-intravenous-igiv-and-immune-globulin
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by FDA, and was posted on the Drug Office website on 15 Aug 2026 and 7 Oct 2026.
Ends/Friday, Oct 9, 2026
Issued at HKT 14:45
|
| |
