Millburn, NJ, United States
Advanced Accelerator Applications USA, Inc. recalls
4 recalls recorded since 2018, most recently on 23 September 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)1
Terminated or completed3
Class I (FDA)0
Ongoing Class II Drugs
- Recall started
- 23 September 2024
- Reason
- CGMP deviations
- Distribution
- FL, MA, NJ, NY, PA, and VA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0007-2025
- Pluvicto, 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 69488-001
Terminated Class III Drugs
- Recall started
- 7 August 2023
- Terminated
- 12 March 2024
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1085-2023
- PLUVICTO 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 694
Terminated Class III Drugs
- Recall started
- 18 March 2022
- Terminated
- 4 January 2023
- Reason
- Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
- Distribution
- Nationwide in the USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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
Terminated Class II Drugs
- Recall started
- 10 January 2020
- Terminated
- 21 July 2023
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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,
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.