Food, drugs, devices › Advanced Accelerator Applications USA, Inc.
Drug recall: NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, kit contains Vial 1 (Reaction vial with l
FDA enforcement event 89885 is a drug recall by Advanced Accelerator Applications USA, Inc. of Millburn, NJ, initiated 18 Mar 2022 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 18% of the 325 drug enforcement events initiated in 2022 carry the same class.
Status: Terminated, terminated 4 Jan 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
"Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies."
Distribution
"Nationwide in the USA and Puerto Rico"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0747-2022 | NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, kit contains Vial 1 (Reaction vial with lyophilized powder), 1 Single dose vial, consisting of 40 mcg of dotate, 5 mcg of 1,10-phenanthroline, 6 mcg of Gentisic acid, 20 mg of D-Mannitol, and Nitrogen; and Vial 2, 1 Single dose vial of… | 14,089 kits | Class III | Terminated | 13 Apr 2022 |
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 |
| 10 Jan 2020 | NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only, Rx Only, Manuf | Drug | Class II | 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: "Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide in the USA and Puerto Rico"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 4 Jan 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.