Netspot Kit
FDA Recall NDC 69488-001
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Netspot (NDC 69488-001). A significant event, classified as Class III, was initiated on Mar 18, 2022 by Advanced Accelerator Applications Usa, Inc. The reported reason for this action was: "Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
Mar 18, 2022
Apr 13, 2022
14,089 kits
Recall Profile & Regulatory Data
Event ID
89885
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Advanced Accelerator Applications USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
Jan 04, 2023
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
Batch or Lot Expiration Information
Lot# (Vial 1)/kit: (F03221004 vial) in kit PG1921014, PG1921015, Exp 16-Mar-2022; (F03221005 vial) in kit PG1921016, PG1921017, Exp 18-Mar-2022; (F03221006 vial) in kit PG1921018, PG1921019, Exp 11-May-2022; (F03221007 vial) in kit PG1921020, PG1921021, Exp 04-Aug-2022
Affected Packages Involved in this Recall
69488-001-40Product
Class II Terminated
Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
Jan 10, 2020
Jan 29, 2020
4295 Kits
Recall Profile & Regulatory Data
Event ID
84685
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Advanced Accelerator Applications USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US and Canada
Termination Date
Jul 21, 2023
Product Description
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.
Batch or Lot Expiration Information
Lot# : PG1919025, Exp. 07/11/2020; PG1919026, PG1919027, Exp. 07/16/2020.
Affected Packages Involved in this Recall
69488-001-40Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
