Home / Recalls / Advanced Accelerator Applications USA, Inc. / D-0799-2020

D-0799-2020 Class II Terminated

Recalled by Advanced Accelerator Applications USA, Inc. — Millburn, NJ

Recall Details

Product Type
Drugs
Report Date
January 29, 2020
Initiation Date
January 10, 2020
Termination Date
July 21, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4295 Kits

Product Description

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).

Distribution Pattern

Nationwide in the US and Canada

Code Information

Lot #: PG1919025, Exp. 07/11/2020; PG1919026, PG1919027, Exp. 07/16/2020.

Other recalls by Advanced Accelerator Applications USA, Inc.

  • D-0007-2025 Class II — Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injec (September 23, 2024)
  • D-1085-2023 Class III — PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injectio (August 7, 2023)
  • D-0747-2022 Class III — NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, k (March 18, 2022)