Administrative Guidance against Nobaruteisu K.K.

ノバルティス株式会社 (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 WelfareApril 17, 2014

Action summary

Company
Original: ノバルティス株式会社
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
April 17, 2014
Issuing authority
Ministry of Health, Labour and Welfare
厚生労働省

Violation

Machine-translated summary — verify against original

When dispensing pharmaceuticals, it is necessary to carefully observe the condition of the medication and confirm that there are no abnormalities. In pharmacies within Saitama Prefecture and medical institutions within Chiba Prefecture, vials contaminated with needle-shaped foreign matter were found, but there are no descriptions of specific violations or methods.

Show original Japanese text

医薬品の交付に当たっては、医薬品の状態を十分に観察し、異常が無いことの確認をする必要があります。埼玉県内の薬局及び千葉県内の医療機関で、針状の異物が混入したボルタレンサポが発見されたが、具体的な違反手口や態様についての記述はない。

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
Nobaruteisu K.K. Romanized
Japanese name
ノバルティス株式会社
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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.