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[HEALTH] · Romania, France · 3 sources

Romania places non‑conforming rabies vaccine lot in quarantine, imports replacement from France

The National Agency for Medicines and Medical Devices in Romania (ANMDMR) announced that a lot of the rabies vaccine VERORAB delivered last week was found to be non‑conforming because the required temperature regime was not maintained during transport. The manufacturer placed the lot in quarantine and a investigation was launched; the entire quantity is expected to be destroyed.

To maintain treatment continuity, ANMDMR approved, on an emergency basis, the rapid import of a replacement lot. Sanofi confirmed that approximately 18,600 doses of VERORAB will arrive from France during the coming week, a supply sufficient for all Romanian hospitals until the next delivery. In the interim, hospitals may redistribute existing stocks as needed.

Entities: ANMDMR · France · Romania · Sanofi · VERORAB