D-0747-2022 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 13, 2022
- Initiation Date
- March 18, 2022
- Termination Date
- January 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,089 kits
Product 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
Reason for Recall
Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
Distribution Pattern
Nationwide in the USA and Puerto Rico
Code Information
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