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9/24/2003

Stop Shipping Gray Imovax Boxes, Firm Says

Cheryl Thompson

Aventis Pasteur is asking pharmacies and other distributors of its Imovax-brand rabies vaccine to stop shipping the older-style gray plastic boxes because they may lack the active ingredient—a vial of freeze-dried suspension of rabies vaccine.

The "Dear Valued Customer" letter dated Sept. 9 instructed distributors with gray plastic boxes of the rabies vaccine in stock to immediately call the Imovax medical information services hot line at 800-835-3587. Based on the quantity and location of the inventory, the company representative would "arrange for appropriate corrective action."

Distributors also were asked to contact the company at 800-704-8308 for help in contacting customers who may have received the gray plastic boxes. 

Company spokesman Len Lavenda said a different letter was sent to physicians and other end users of the product. It was those persons, he said, who must—as the Food and Drug Administration instructed in an online notice posted Sept. 23—"open all the gray plastic boxes of IMOVAX Rabies Vaccine in your inventory, regardless of lot number, to confirm inclusion of the vaccine vial."

Information about the possibility of missing vials was first communicated Sept. 5 by the Centers for Disease Control and Prevention via its Morbidity & Mortality Weekly Report.

Imovax's gray "tamperproof unit dose plastic box" of rabies vaccine has been changed to a cardboard carton with a transparent cover that can be used to check the contents, the company indicated in its letter to distributors. Lavenda said Aventis Pasteur started shipping the new packages in July.

Reports of missing vaccine vials have accounted so far for less than 1 percent of the older packages shipped by the company, Lavenda said.