Generic Name: Fresh Frozen Human Plasma; Brand Name: Fresh Frozen Plasma-lr “japanese Red Cross” 240
Recall Summary Fresh Frozen Plasma-LR "Japanese Red Cross" 240 (lot 21-2223-2674, 400mL) manufactured by the Japanese Red Cross is being recalled because the donor reported using medication that could affect blood product quality. The product has not been used by patients, so no health injuries have occurred. Healthcare facilities are being asked to return the unused product.
- Recalling firm
- Name of Manufacturer/Distributor: Japanese Red Cross Society Address of Manufacturer/Distributor: 1-2-1 Shiba-koen, Minato-ku, Tokyo, Japanese Red Cross Society Annex Type of License: Class 1...
- Product
- Lot: 対象ロット： ２１‐２２２３‐２６７４ 数量 ： ４００ｍＬ相当由来 １本 出荷時期 ： 令和７年１０月１０日. Use: 血液凝固因子の補充 （１）複合性凝固障害で、出血、出血傾向のある患者又は手術を行う患者 （２）血液凝固因子の減少症又は欠乏症における出血時で、特定の血液凝固因子製剤がないか又は 血液凝固因子が特定できない場合. Health hazards: 当該血液製剤は、患者に使用されていないため、健康被害はありません。
- Reason
- In accordance with the procedures for handling post-donation information, we investigated a blood donor who reported having taken medication that could potentially affect the quality of blood products. Since the blood products manufactured from the donated blood had not yet been used, we decided to retrieve the products from the medical institution and recall them.
- Classification
- Class I
- Category
- drug recall
- Country
- Japan
- Agency
- PMDA-DRUG
- Recall date
- 2026-06-10
- Status
- Ongoing
Official recall notice from PMDA-DRUG
Recall details on Nibble Recalls: https://trynibble.app/recalls/c429eb96-5692-4bc2-9b1e-cf1fbf9659fb