Where it's made
This label doesn't name the factory that makes the drug. Companies don't have to print it on the label. The maker's name is often on the stock bottle your pharmacy used; you can ask the pharmacist. See the plants Advanced Accelerator Applications USA, Inc names for other drugs.
Recalls
- Mar 18, 2022 · Class III · Advanced Accelerator Applications USA, Inc.
Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
Lots: Lot # (Vial 1)/kit: (F03221004 vial) in kit PG1921014, PG1921015, Exp 16-Mar-2022; (F03221005 vial) in kit PG1921016, PG1921017, Exp 18-Mar-2022; (F03221006 vial) in kit PG1921018, PG1921019, Exp 11-May-2022; (F03221007 vial) in kit PG1921020, PG1921021, Exp 04-Aug-2022 - Jan 10, 2020 · Class II · Advanced Accelerator Applications USA, Inc.
Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
Lots: Lot #: PG1919025, Exp. 07/11/2020; PG1919026, PG1919027, Exp. 07/16/2020.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Dotatate Gallium Ga-68: every company that makes it
- Form
- kit, intravenous
- Strength
- 40 ug
- Approval
- NDA NDA208547
- On the market since
- Jun 1, 2016
- Package NDCs
69488-001-40- Official label
- DailyMed (National Library of Medicine), updated Jul 6, 2026
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?