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6/28/2004

Gammagard S/D Lot Withdrawn by Baxter

Cheryl A. Thompson

Baxter Healthcare Corp. announced June 24 that it was withdrawing Gammagard S/D lot LE08D030AA, containing 10 g of intravenous immunoglobulin, from the market due to a high number of allergic reactions in patients who received a dose from this lot.

The action was described by the company as a market withdrawal, not a recall.

According to the Food and Drug Administration (FDA), a market withdrawal occurs when a product has a minor violation that would not be subject to legal action by the agency. An FDA-provided example of a market withdrawal is a firm's removal of a product from the market because of evidence of tampering without signs of manufacturing or distribution problems.

Baxter said it was instituting the market withdrawal as a "precautionary measure." Health care providers and patients still in possession of vials from lot LE08D030AA but not the June 24 letter from the company should call customer service at 800-423-2090 to arrange for return of the vials.

FDA reported that none of the Gammagard-related allergic reactions have been life-threatening, although two of the events involved the patients' respiratory airway and all patients required medical intervention.