自主回収 against Moderuna K.K.
Action summary
- Company
- Moderuna K.K.RomanizedOriginal: モデルナ株式会社Corporate Number: 1011501009049
- Governing law
- Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices薬機法
- Action type
- 自主回収自主回収
- Action date
- Unknown
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
Regarding the Moderna COVID-19 vaccine, multiple vaccination facilities reported the presence of foreign matter in one lot (Lot 3004667) in an unused state. As a result, the lot was voluntarily recalled. Although no reports of foreign matter contamination were received for this lot, two other lots (Lot 3004734 and Lot 3004956), manufactured using the same equipment during the same period, were also voluntarily recalled.
Show original Japanese text
モデルナ社製の新型コロナワクチンについては、1ロット(Lot 3004667)に未使用の状態での異物の混入が複数の接種施設より報告されたことから、当該ロットの自主回収が行われ、また異物混入の報告はないものの当該ロットと同時期に同一の設備で製造された2ロット(Lot 3004734及びLot 3004956)の自主回収が行われています。
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
- Moderuna K.K. Romanized
- Japanese name
- モデルナ株式会社
- Corporate Number
- 1011501009049
- Registered address
- 東京都荒川区町屋4丁目21番3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.