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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 (English only) |
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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the following lots of immune globulin intravenous (IGIV) and immune globulin subcutaneous (IGSC) have been voluntarily withdrawn by the manufacturers as a precautionary measure, due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically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:
- Octagam 10% (lot number: K139B8541, K140A8561, K139A8561; manufacturer: Octapharma)
- Privigen (lot number: P100287718, P100371288, P100366291, P100356115, P100349929, P100287723; manufacturer: CSL Behring)
- Hizentra (lot number: P100369103, P100369102, P100343632, P100340460; manufacturer: CSL Behring)
- Gamunex-C (lot number: A1GLE01642, A1GLE01582, A4GLE01512, A3GLE01432, A4GKE01092, A4GKE01012, A1GKF00042, A1GKF00032, A1GKF00022, A1GKF00052, A1GLE01602, A3GLE01462, A4GLE01482, A1GLE01542, A1GLE01532; manufacturer: Grifols)
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
In Hong Kong, the following pharmaceutical products are registered by CSL Behring Asia Pacific Limited (CSL Behring):
- Privigen Solution For Infusion 5g/50ml (HK-62854)
- Privigen Solution For Infusion 10g/100ml (HK-62855)
- Privigen Solution For Infusion 20g/200ml (HK-62856)
- Privigen Solution For Infusion 2.5g/25ml (HK-63836)
- Hizentra Solution For Subcutaneous Injection 10g/50ml (HK-65093)
- Hizentra Solution For Subcutaneous Injection 4g/20ml (HK-65094)
- Hizentra Solution For Subcutaneous Injection 1g/5ml (HK-65095)
- Hizentra Solution For Subcutaneous Injection 2g/10ml (HK-65096)
All products are prescription-only medicines. As confirmed with CSL Behring, the affected lots have not been imported into 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 with LCH, the affected lots have not been imported into Hong Kong.
Octagam 10% is not a registered pharmaceutical product in Hong Kong.
Related news was previously issued by Health Canada, and was posted on the Drug Office website on 24 Feb 2022.
Ends/Friday, Mar 4, 2022
Issued at HKT 16:00
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