FDA-Drug2020-01-29Class II
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.
Advanced Accelerator Applications USA, Inc.
Hazard
Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
Sold states
Nationwide in the US and Canada
Affected count
4295 Kits
Manufactured in
57 E Willow St, Millburn, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0799-2020Don't want to check this manually?
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