Connaught Labs' Feb. 23 withdrawal of its diptheria-tetanus-pertussis vaccine adsorbed lot number 8M91039 was initiated after a routine quality assurance inspection. Connaught said it "determined that four vials of Inflogen, an inactivated equine influenza vaccine, in storage at the plant were incorrectly labeled as DTP." The company is coordinating withdrawal activities with FDA. The lot contained 45,909 vials, approximately 19,083 of which were shipped to 1,865 doctors, pharmacists and distributors. Each is being contacted by telephone and telegram, Connaught said. The firm added that there is no evidence that any vials containing Inflogen left the plant.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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