Additional IGIV and IGSC Lots Withdrawn Due to Allergic Reactions

Manufacturers have voluntarily withdrawn additional lots of immune globulin intravenous (IGIV) and immune globulin subcutaneous (IGSC) products due to a higher rate of allergic/hypersensitivity reactions, some of which were considered medically significant.

The additions include one lot each of Gammaked and Gamunex-C (Grifols), along with two lots of Yimmugo (Biotest AG).

The Food and Drug Administration said facilities should immediately examine their stock, cease use of any affected lots and return the product to the point of purchase for replacement.

The full list of withdrawn lots, expiration dates and manufacturers is available in FDA’s safety and availability notice.