Switzerland’s Octapharma AG has issued an urgent, voluntary recall of one lot of its Octagam immune globulin used intravenously after several reports of allergic type skin reactions.
The lot Octagam Immune Globulin Intravenous (Human) 5% being recalled is K551A8441 and was manufactured at the company’s facility in Vienna, Austria. The plant received FDA approval to produce the drug a little over a year ago.
No other lots of Octagam are affected by the recall, the company said in a posting on the FDA website.
Octagam is used to treat primary humoral immunodeficiencies, such as congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome and other severe combined immunodeficiencies.
No serious injuries from the products have been reported.
In October, Octapharma shelled out about $91 million to gain exclusive global license to certain intellectual property behind Glycotope’s recombinant technology as well as a minority stake in the German biotech.
-see the FDA posting
Octapharma buys into Glycotope with an €80M cash deal