FDAFDA · Food and drugs·Recall number D-0747-2022
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
Published April 13, 2022 · Recall initiated: March 18, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- NETSPOT
- Manufacturer
- Advanced Accelerator Applications USA, Inc.
- Distributor
- Nationwide in the USA and Puerto Rico
- Lot
- 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
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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