Financial Daily from THE HINDU group of publications
Saturday, Feb 11, 2006
Financial Daily from THE HINDU group of publications Saturday, Feb 11, 2006 |
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Marketing
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Standards & Benchmarks Sanofi-Aventis recalls 30 batches of anticoagulant drug Our Bureau
Mumbai , Feb. 10 SANOFI-AVENTIS has voluntarily recalled 30 batches of anticoagulant enoxaparin, sold under the brandnames Lovenox and Clexane, to markets in Europe, South America, Asia, and Africa. India is also in the loop, with the local affiliate having imported and sold three batches of the product. "In India, our affiliate Aventis Pharma Ltd has imported and sold only three batches with the following batch numbers: Clexane 20 mg (batch no. 2713), Clexane 40 mg (batch no. 4811) and Clexane 80 mg (batch no. 8987)," a note from Sanofi-Aventis said. The decision was taken following quality control testing and a subsequent investigation that identified the potential for over-concentration of the active ingredient in a limited number of syringes, the company said. Enoxaparin, the active ingredient is not the subject of this recall, the company said. Sanofi-Aventis does not currently anticipate an impact on the availability of enoxaparin. The recall concerns batches filled at a single facility. Sanofi-Aventis is informing and liaising with health authorities in all countries affected, in compliances with applicable regulations, the note added. Patients, healthcare professionals, pharmacists, and wholesalers in the affected countries are being informed of the recall and provided with all necessary information and support, the company said.
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