NETSPOT — Class II drug recall D-0799-2020
Terminated recall by Advanced Accelerator Applications USA, Inc., reported 2020-01-29, distributed nationwide. Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2)
| Recall number | D-0799-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Accelerator Applications USA, Inc., Millburn, NJ, United States |
| Recall initiated | 2020-01-10 |
| Classified | 2020-01-22 |
| Reported by FDA | 2020-01-29 |
| Terminated | 2023-07-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 4,295 kits |
| Reason classes | packaging |
| NDC | 69488-0001, 69488-0001-40 |
| Lot numbers | PG1919025, PG1919026, PG1919027 |
| Expiration dates | 2020-07-11, 2020-07-16 |
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.
Reason for recall
Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
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-0799-2020. 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.