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, Manu…
- Recall date
- January 10, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0799-2020
- FDA classification
- Class II
- Brand / firm
- Advanced Accelerator Applications USA, Inc.
- Sold / distributed
- Nationwide in the US and Canada
Why it was recalled
Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
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.
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