Administrative Guidance against Huaiza K.K.
Action summary
- Company
- Huaiza K.K.RomanizedOriginal: ファイザー株式会社Corporate Number: 5011001126167
- Governing law
- Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices薬機法
- Action type
- Administrative Guidance行政指導
- Action date
- September 15, 2021
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
The formulation may contain white particles (floaters) derived from the product, but when diluted and dissolved, it can be used without issue. During dilution, gently invert the vial 10 times before and after dilution. Occasionally, even after dilution and gentle inversion, white particles derived from the product may remain undissolved. In such cases, do not use the vial with the residual particles and use another vial. The white particulate matter derived from the product is not associated with safety concerns. No extraneous foreign matter has been confirmed among the reported white particulate matter. Regarding the white particulate matter reported in multiple cases from different municipalities for lot number FF5357, investigations are ongoing. The results will be promptly announced and reported to the Ministry of Health, Labour and Welfare.
Show original Japanese text
製剤特性として製品由来の白色の微粒子（浮遊物）を含むことがあるが、希釈し溶解した場合は問題なく使用可能。希釈時は、希釈前及び希釈後に、ゆっくりと10回転倒混和すること。稀に、希釈後、転倒混和しても、製品由来の白色の微粒子（浮遊物）が溶解せずに残ることがある。その場合は当該バイアルは使用せず、他のバイアルを使用すること。なお、製品由来の白色浮遊物は安全性への影響はない。これまでに白色浮遊物として報告されたもので外来性の異物は確認されていない。既にロット番号「FF5357」に関し、複数の自治体より相談されている白色浮遊物については、調査中であり、結果については速やかに公表し、厚労省に報告する。
Source
Original Ministry of Health, Labour and Welfare announcement (in Japanese)The original Japanese disclosure is the authoritative record.
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Language
日本語版を見る (Japanese)Company info
- English name
- Huaiza K.K. Romanized
- Japanese name
- ファイザー株式会社
- Corporate Number
- 5011001126167
- Registered address
- 東京都渋谷区代々木３丁目２２番７号
About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.