NETSPOT Dotatate Kit (Advanced Accelerator) – Subpotent Drug (2022)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Advanced Accelerator Applications USA, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Advanced Accelerator Applications USA, Inc. is recalling NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, kit contains Vial 1 ( due to Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026