Food, drugs, devices › Advanced Accelerator Applications USA, Inc.
Drug recall: NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only, Rx Only, Manuf
Advanced Accelerator Applications USA, Inc. (Millburn, NJ) initiated this drug recall on 10 Jan 2020; FDA lists 1 product record under event 84685, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 64% of the 342 drug enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 21 Jul 2023. Initiation: voluntary: firm initiated. Advanced Accelerator Applications USA, Inc. has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Advanced Accelerator Applications USA, Inc., Millburn, NJ.
Reason for recall
"Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2)."
Distribution
"Nationwide in the US and Canada"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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. | 4295 Kits | Class II | Terminated | 29 Jan 2020 |
Context
Other enforcement events for Advanced Accelerator Applications USA, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 23 Sep 2024 | Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufac | Drug | Class II | 1 |
| 7 Aug 2023 | PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL Single-dose vial, Manufacturer | Drug | Class III | 1 |
| 18 Mar 2022 | NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, kit contains Vial 1 (Reaction vial with l | Drug | Class III | 1 |
All 4 events for Advanced Accelerator Applications USA, Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2)."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide in the US and Canada"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 21 Jul 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.