Drug 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.
D-0799-2020
Product summary
- Event
- Event 84685
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4295 Kits
- Official record key
drug-enforcement:D-0799-2020
Official wording
Reason: Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
Code information: Lot #: PG1919025, Exp. 07/11/2020; PG1919026, PG1919027, Exp. 07/16/2020.
Distribution pattern: Nationwide in the US and Canada
Derived failure modes
-
Unknown
Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).