FDAFDA · Food and drugs·Recall number D-0799-2020
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.
Published January 29, 2020 · Recall initiated: January 10, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- NETSPOT
- Manufacturer
- Advanced Accelerator Applications USA, Inc.
- Distributor
- Nationwide in the US and Canada
- Lot
- Lot #: PG1919025, Exp. 07/11/2020; PG1919026, PG1919027, Exp. 07/16/2020.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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