Advanced Accelerator Applications USA, Inc. recalls NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only, Rx Only, Manuf
Recalled January 29, 2020 · FDA recall D-0799-2020 · Advanced Accelerator Applications USA
Hazard
Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2). · FDA Class II
Units
4295 Kits
Sold at
Nationwide in the US and Canada
Description
Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
Product
NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only, 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 →