Aventis recalls 30 batches of Enoxaparin syringes

Aventis Pharma today announced that Sanofi-Aventis has recalled 30 batches of the anticoagulant enoxaparin (Lovenox, Clexane).

According to a release issued by Aventis to the BSE today, the company, which is the Indian affiliate of Sanofi-Aventis, has imported and sold 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).

"Patients, healthcare professionals, pharmacists and wholesalers are being informed of the recall and provided with all necessary information and support," the release added.

The release further said that the enoxaparin active ingredient is not the subject of the recall.

"The decision was taken following quality control testing and a subsequent investigation, which identified the potential for over-concentration of the active ingredient in a limited number of syringes. The recall concerns batches filled at a single facility and delivered to Europe, Latin America, Asia and Africa. It follows a modification of the syringe filling process, which was implemented in April 2005 in compliance with Good Manufacturing Practices (GMP) and local regulations," the release said.