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 Singl
Check against the official notice below — it lists the full affected range.
Advanced Accelerator Applications USA, Inc. is recalling 14,089 NETSPOT kits distributed nationwide in the USA and Puerto Rico. The kits are used to prepare Ga 68 dotatate injection and contain a lyophilized powder in Vial 1. The recall was initiated because stability studies found that Vial 1 showed low out-of-specification results for assay, meaning the drug was subpotent. The affected kits are identified by specific lot numbers: F03221004, F03221005, F03221006, and F03221007 in kit lots PG1921014 through PG1921021, with expiration dates ranging from March 16, 2022 to August 4, 2022.
The recall source does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
Reason for recall: Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies. Distribution: Nationwide in the USA and Puerto Rico Quantity: 14,089 kits Lot/code info: 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 record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.