HPRA 通知召回 Flebogamma DIF 100 mg/ml 输液两个批次（EU/1/07/404/007-008）
Flebogamma DIF 100 mg / ml solution for infusion, EU/1/07/404/007-008, batch recall
HPRA 通知召回 Flebogamma DIF 100 mg/ml 输液的两个批次，因超敏型反应报告增加，从患者层面预防性召回。
通知列出两个批次从患者层面召回的级别与药房需执行的操作，并说明尚未发现生产或质量缺陷。
14/09/2026
Medicines for human use Recall
We wish to advise you that the below-listed batch numbers of Flebogamma DIF 100 mg / ml solution for infusion are being recalled with immediate effect.
Impacted units of two batches are being recalled from patient level as a precaution following increased reporting of hypersensitivity type reactions. To date, no manufacturing issues or quality defects have been identified.
The recall letter to pharmacists dated September 11, 2026 can be found in the Documents section at the bottom of this page.
Product information
- Product name
- Flebogamma DIF 100 mg / ml solution for infusion (10 g / 100 ml vial) Flebogamma DIF 100 mg / ml solution for infusion (20 g / 200 ml vial)
- Active substance
- Human normal immunoglobulin
- Authorisation holder
- Instituto Grifols S.A.
- Authorisation number
- See table in Reference section below.
- Serial or batch number and expiry date
- See table in Reference section below.
- Human or veterinary medicine
-
Human Medicine
- Target audience
-
Pharmacists
- Recall level
-
Patient level
Actions to be taken
Information for Pharmacists
Pharmacists are requested to perform the following actions:
- For stock within your pharmacy or facility, immediately identify and quarantine any units of the above-listed batches. For hospital pharmacies, clinics, nursing homes and other such facilities, this includes units at wards, clinics and any other relevant locations within your facility.
- Identify patients to whom these batches may have been dispensed. Contact those patients or their carers via telephone to request they return any unused units to your pharmacy.
- Please bring the contents of the recall letter (in the Documents section at the bottom of this page) to the attention of relevant healthcare professionals.
- If you have supplied any units of these batches to another pharmacy or facility, please forward a copy of the recall letter (in the Documents section at the bottom of this page) to them and request they return any unused units to your pharmacy.
- Contact your wholesaler to arrange uplift of the quarantined units.
Reference
| Product | Authorisation No. | Batch No | Expiry date |
| Flebogamma DIF 100 mg / ml solution for infusion (10 g / 100 ml vial) | EU/1/07/404/007 | G04K139941 | 22/09/2027 |
| Flebogamma DIF 100 mg / ml solution for infusion (20 g / 200 ml vial) | EU/1/07/404/008 | G04K192351 | 18/12/2027 |
Documents
来源：HPRA 人用药批次召回 · hpra.ie