Reported Jan 29, 2020 · Terminated
NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only, Rx Only,…
Advanced Accelerator Applications USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Advanced Accelerator Applications USA, Inc. · 57 E Willow St · Millburn, NJ · 07041-1416
Is this the product you have?
- NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only, Rx Only
- Manufactured forAdvanced Accelerator Applications USA, Inc. by Gipharma S.r.l. Strada Crescentino snc, 13040 Saluggia (Vc), Italy, NDC 69488-001-40
- Lot codes and dates
Lot #: PG1919025Exp. 07/11/2020PG1919026PG1919027Exp. 07/16/2020
- Amount recalled
- 4295 Kits
Where it was sold
- Nationwide
Why it was recalled
Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
This product could cause temporary or reversible health problems — stop using it.
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