The company is pulling 12 lots of its injection kits that contain the 19-gauge filter needle or the 18-gauge filter needle, according to a Sept. 29 post from the FDA.
Apellis is now exclusively distributing 18-gauge needle kits because “internal structural variations were identified in the specific 19-gauge x 1½ inch filter needle included in certain injection kits,” according to an Aug. 22 news release.
“A causal relationship has not been established between the structural variations in this 19-gauge filter needle and the rare events of retinal vasculitis,” according to the FDA’s post.
