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 694

FDA recall notice · announced January 29, 2020 · Advanced Accelerator Applications

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Reason for recall

Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).

Notes

Distribution: Nationwide in the US and Canada
Lot/code information: Lot #: PG1919025, Exp. 07/11/2020; PG1919026, PG1919027, Exp. 07/16/2020.
Quantity: 4295 Kits
Status: Terminated
Products in this recall event:
- 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. Stra (D-0799-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.