Advanced Accelerator Applications USA, Inc. Recall: NETSPOT (kit for the preparation of Ga
Advanced Accelerator Applications USA, Inc. Recall: NETSPOT (kit for the preparation of Ga is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Advanced Accelerator Applications USA, Inc.; Product: NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, kit contains V
| Recalling firm | Advanced Accelerator Applications USA, Inc. |
|---|---|
| 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 |
| Reason for recall | Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies. |
| Classification | Class III (least serious — unlikely to cause adverse health consequences) |
| Status | Terminated |
| Distribution | Nationwide in the USA and Puerto Rico |
| Recall initiated | 20220318 |
| Recall number | D-0747-2022 |
| Category | drug |
| State | NJ |
| Country | United States |
$29/mo
Try RecallGuard →