Advanced Accelerator Applications USA, Inc. recalls NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, kit contains Vial 1 (Reaction vial with l
Recalled April 13, 2022 · FDA recall D-0747-2022 · Advanced Accelerator Applications USA
Hazard
Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies. · FDA Class III
Units
14,089 kits
Sold at
Nationwide in the USA and Puerto Rico
Description
Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
Product
NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, kit contains Vial 1 (Reaction vial with lyophilized powder), 1 Single dose vial, consisting of 40 mcg of dotate, 5 mcg of 1,10-phenanthroline, 6 mcg of Gentisic acid, 20 mg of D-Mannitol, and Nitrogen; and Vial 2, 1 Single dose vial of reaction buffer, Rx Only, Manufactured for: Advanced Accelerator Applications USA, Inc., by: Gipharma S.r.l., Strada Crescentino snc, 13040 Saluggia (Vc), Italy, NDC 69488-001-40
Manufacturer(s)
Advanced Accelerator Applications USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →