BETHESDA, MD 05 Apr 2013—Biotest Pharmaceuticals Corporation on April 2 recalled Bivigam lot 120016, a 10% i.v. immune globulin liquid product in 100-mL vials, because particles were seen in at least one of the lot's reserve vials during a routine inspection.
The recall notice, circulated today by FDA, states that particles were not seen during inspections of reserve vials from other Bivigam lots.
Biotest said it wants all vials from lot 120016 returned to the company's facility in Boca Raton, Florida.
FDA approved the biologics license for Bivigam in December 2012. The company in early February announced it had made the first commercial sales and shipments of the product.