Agency classClass IIIOur severity:Moderate FDA (Drugs)·D-0747-2022·Announced 2022-04-13

NETSPOT prescription drug kit recalled for subpotency in vial 1

Advanced Accelerator Applications recalls approximately 14,089 NETSPOT kits distributed nationwide due to subpotency detected during stability studies. The affected lots contain insufficient active ingredient concentration.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This recall is classified as FDA Class III, which are typically scored as 1 or 2. The subpotency was discovered proactively during stability studies rather than through clinical use or field incidents. While subpotency represents a quality defect, the absence of any reported illnesses or injuries and the FDA's own Class III classification support a Moderate score.

Plain-English summary

Advanced Accelerator Applications USA, Inc. is recalling approximately 14,089 NETSPOT kits distributed nationwide in the USA and Puerto Rico. The recall was initiated because stability studies found low out-of-specification results for Vial 1 assay. The affected kits contain insufficient active ingredient concentration.

The affected lot numbers are F03221004, F03221005, F03221006, and F03221007 in various kit configurations with expiration dates from March 16, 2022 through August 4, 2022. The specific affected kits are: F03221004 in kits PG1921014 and PG1921015 (expires March 16, 2022); F03221005 in kits PG1921016 and PG1921017 (expires March 18, 2022); F03221006 in kits PG1921018 and PG1921019 (expires May 11, 2022); and F03221007 in kits PG1921020 and PG1921021 (expires August 4, 2022).

Healthcare providers and facilities that have distributed or used affected NETSPOT kits should stop using them immediately and contact Advanced Accelerator Applications USA, Inc. for guidance. Patients who may have received injections prepared from affected kits should consult their healthcare provider regarding the recall.

The recalled product

Product: NETSPOT (68GA-DOTATATE)
Brand: NETSPOT
Manufacturer: Advanced Accelerator Applications USA, Inc.
Category: Drug — Radiopharmaceutical
Hazard: subpotency
Affected units: 14,089

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same brand · NETSPOT

Moderate
FDA Recalls NETSPOT Kits Due to Defective Aluminum Cap Crimp
FDA (Drugs) · 2020-01-29

Same manufacturer · Advanced Accelerator Applications USA, Inc.

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Same hazard · subpotency