Use cautionDrug recall · FDA · Published January 10, 2020
Advanced Accelerator Applications NETSPOT Kit Recall: Loose Cap Risk
Advanced Accelerator Applications recalls NETSPOT kits for Ga 68 dotatate injection due to loose aluminum cap in dilution buffer vial. This could cause contamination during preparation. Contact for details.
Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
Take action
Contact the company
📍Recalling firmAdvanced Accelerator Applications USA, Inc.57 E Willow St · Millburn, NJ 07041-1416
✎ GovInfoNow plain-language explainer
Advanced Accelerator Applications is recalling NETSPOT kits for Ga 68 dotatate injection because the container has a loose aluminum cap. This defect could lead to contamination during the injection preparation process, which is risky for patients receiving the medication. Read more at govinfonow.com/recall/37479-advanced-accelerator-applications-netspot-kit-recall-loose-cap-risk.
“Advanced Accelerator Applications NETSPOT Kit Recall: Loose Cap Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37479-advanced-accelerator-applications-netspot-kit-recall-loose-cap-risk. Based on FDA recall #D-0799-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0799-2020%22&limit=1).
The FDA announced on Jan. 10, 2020, that Advanced Accelerator Applications USA, Inc. is recalling NETSPOT kits due to a defective container with a loose aluminum cap crimp for the dilution buffer vial. The agency classified this as a Class II recall affecting 4,295 units distributed nationwide in the U.S. and Canada.
How to tell if you have it
Brand: Advanced Accelerator Applications
Product: NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only, Rx Only
NDC: 69488-001-40
Lot codes: PG1919025 (Exp. 07/11/2020); PG1919026, PG1919027 (Exp. 07/16/2020)
Quantity: 4,295 Kits
The hazard
The recall involves a defective container where the loose aluminum cap crimp for the dilution buffer vial is present in the NETSPOT Kit. The FDA stated this defect poses a risk to the sterility and integrity of the kit.
Context
GovInfoNow's records show Advanced Accelerator Applications USA, Inc. has had three other recalls since March 18, 2022, including a Sept. 23, 2024 recall for CGMP deviations and an Aug. 7, 2023 recall for incorrect labeling. Other recent recalls of similar products include Lupin's April 24, 2026 Liraglutide injection recall for particulate matter hazard and Baxter's July 24, 2026 Cefazolin injection recall for particulate matter risk.
How to tell if you have this one
Check for NETSPOT kits labeled with NDC 69488-001-40, manufactured by Gipharma S.r.l. in Italy. Lot numbers PG1919025, PG1919026, or PG1919027 with expiration dates up to July 2020.
Brand
Advanced Accelerator Applications
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Verify the lot number and expiration date on the NETSPOT kit packaging to confirm if it's recalled.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Nationwide in the US and Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 3.5 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0799-2020 (January 10, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0799-2020 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.