Apellis Pharmaceuticals, a biotech drug company based in Waltham, Mass., recalled more than 61,000 injection needle kits after eight retinal vasculitis cases were reported.
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.