自主回収 against Moderuna K.K.

モデルナ株式会社 (Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices)
Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical DevicesMinistry of Health, Labour and Welfare

Action summary

Company
Moderuna K.K.Romanized
Original: 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

Machine-translated summary — verify against original

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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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
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About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.