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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Advanced Accelerator Applications USA, Inc.
- Reason for Recall:
- Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0747-2022
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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.
Advanced Accelerator Applications USA
Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).