FDAMarch 18, 2022drug
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 Si...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
What to do
FDA enforcement status: Terminated
Brands named
advanced accelerator applicationsadvancedadvanced accelerator
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCHonlyne LED Party Favors Recalled Due to Risk of Serious Injury Death from Battery Ingestion; Violate Mandatory Standard for Consumer Products with Button Cell Batteries; Sold by Huizhou Rongheng Network Technology2026-06-25
- FDABrand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI-1601-04 Software Version: N/A Product Description: The HiResolution Bionic Ear System is a cochlear implant designed to provide useful hearing to individuals with severe-to-profo...2026-04-30
- FDABrand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5501-120; CI-5501-130; CI-5501-140; CI-5501-150; CI-5501-190; CI-5501-240; CI-5501-250; CI-5501-260; CI-5501-270; CI-5501-280 Software Version: Not Applicable Product Description: ...2026-03-23
- FDAIBA Proton Therapy System - PROTEUS 2352026-02-03
- FDABrand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-1502025-11-27
- FDATESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-012025-10-03
- FDATribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traum...2025-09-02
- FDATESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose vial per carton, For intramuscular injection only, Rx Only, ADVANCED PHARMACEUTICAL TECHNOLOGY, INC., 132 South Central Avenue, Elmsford, NY 10523. NDC 57377-200-012025-05-30
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