January 2020 FDA Recall Netspot by Advanced Accelerator Applications Usa, Inc.
D-0799-2020 - Defective Container

This Class II drug recall was voluntarily initiated by Advanced Accelerator Applications Usa, Inc. on January 10, 2020 for the product Netspot. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0799-2020

Reason for Recall
Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
Initiated
01-10-2020
Reported
01-29-2020
Quantity
4295 Kits

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84685
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Accelerator Applications USA, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the US and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-21-2023
Product Description About Product Description
Full technical description of the product.
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

69488-001-40 Netspot