Octapharma issues recall of one lot of its immune globulin Octagam

Octagam voluntary recall.

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.


[Infographic] Machine Learning, Statistics and Optimizing Outcomes

In our infographic, we outline the potential of fusing machine learning and statistics algorithms together to more efficiently analyze clinical trial data output and ultimately revolutionize clinical research.

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

Related Article:
Octapharma buys into Glycotope with an €80M cash deal


Suggested Articles

Novartis' AveXis will use Catalent for some manufacturing of its newly approved gene therapy Zolgensma and more manufacturing news of note.

Pharmacy chain Rite Aid has partnered with Google to have their drug recycling stations easily searchable on Google Maps. 

Precision BioSciences says it will have a manufacturing facility for its off-the-shelf CAR-T therapies up and running in the fourth quarter.