FDAJanuary 10, 2020drug
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 recall recorded by the U.S. Food & Drug Administration.
The hazard
Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
What to do
FDA enforcement status: Terminated
Brands named
advanced accelerator applicationsadvancedadvanced accelerator
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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