FDA Drug recall D-0799-2020
NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only, Rx Only, Manufactured for: Advanc…
- FDA Drug
- Class II
- terminated
- Published 2020-01-29
On 2020-01-29 the FDA classified a Class II recall of NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only, Rx Only, Manufactured for: Advanc… by Advanced Accelerator Applications Usa, citing defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0799-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-10 |
| Published | 2020-01-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Advanced Accelerator Applications Usa |
| Distribution | US |
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
Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
Identifiers
| ndc | 69488-001-40 |
|---|---|
| code_info | Lot #: PG1919025, Exp. 07/11/2020; PG1919026, PG1919027, Exp. 07/16/2020. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0799-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.