NETSPOT — Class III drug recall D-0747-2022

Terminated recall by Advanced Accelerator Applications USA, Inc., reported 2022-04-13, distributed nationwide. Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.

Recall number	`D-0747-2022`
Product type	Drug
Classification	Class III
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Advanced Accelerator Applications USA, Inc., Millburn, NJ, United States
Recall initiated	2022-03-18
Classified	2022-04-06
Reported by FDA	2022-04-13
Terminated	2023-01-04
Distributed	Nationwide (US)
Quantity	14,089 kits
Reason classes	potency, specification failure
NDC	`69488-0001`, `69488-0001-40`
Lot numbers	`PG1921014`, `PG1921015`, `PG1921016`, `PG1921017`, `PG1921018`, `PG1921019`, `PG1921020`, `PG1921021`
Expiration dates	`2022-03-16`, `2022-03-18`, `2022-05-11`, `2022-08-04`

Product

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

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0747-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.