US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jan 10, 2020 (7 years ago)

NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).

What was recalled

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.

Recalling firm
Advanced Accelerator Applications USA, Inc.
NDC code
69488-001-40
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0799-2020

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.