Recall Register

Food, drugs, devices › Firms

Advanced Accelerator Applications USA, Inc.

FDA recalling firm · 4 enforcement events · 4 product records · 2020–2024 · NJ

Advanced Accelerator Applications USA, Inc. has 4 FDA enforcement events on this register (4 product records) between 2020 and 2024: 4 drug; the busiest year was 2020 with 1.

0% of its events are Class I; the most common class is Class II (2). 1 event is listed as ongoing; the recalling firm's address is in NJ.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
23 Sep 2024Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufacturer Advanced Accelerator Applications, 57 E. Willow Street, NJ 07041, Millburn USA. NDC 69488-0010-61DrugClass II1Ongoing
7 Aug 2023PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL Single-dose vial, Manufacturer: Advanced Accelerator Appllications USA, Inc., 57 E. Willow Street NJ 07041, Milburn, USA, NDC 69488-010-61DrugClass III1Terminated
18 Mar 2022NETSPOT (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…DrugClass III1Terminated
10 Jan 2020NETSPOT, (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.DrugClass II1Terminated

By type and class

Drug4
Class II2
Class III2

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

20
21
22
23
24
25
26
Enforcement events for Advanced Accelerator Applications USA, Inc. by year initiated.

Questions and answers

How many FDA recalls has Advanced Accelerator Applications USA, Inc. had?

4 enforcement events (4 product records) on this register, 2020–2024: 4 drug.

Are any Advanced Accelerator Applications USA, Inc. recalls ongoing?

1 event is listed as ongoing in the current openFDA export.

What class are Advanced Accelerator Applications USA, Inc. recalls?

2 Class II, 2 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.