Advanced Accelerator Applications USA, Inc.: Drug Recall

Recall #D-0747-2022 · 03/18/2022

Class III: Low Risk

Recall Details

Recall Number: D-0747-2022
Classification: Class III
Product Type: Drug
Recalling Firm: Advanced Accelerator Applications USA, Inc.
Status: Terminated
Date Initiated: 03/18/2022
Location: Millburn, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 14,089 kits

Reason for Recall

Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.

Product Description

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 reaction buffer, 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

Distribution Pattern

Nationwide in the USA and Puerto Rico

Other Recalls by Advanced Accelerator Applications USA, Inc.

Class II: Risk 09/23/2024

CGMP deviations
Class III: Low Risk 08/07/2023

Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date

View all recalls by Advanced Accelerator Applications USA, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.