FDA recall D-0799-2020

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.

Reason for recall

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

Distribution

Nationwide in the US and Canada

Key facts

Status

Terminated

Initiation date

2020-01-10

Report date

2020-01-29

Termination date

2023-07-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Millburn, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0799-2020