Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Reason Super Potent and Failed Reconstitution Time
Reason Sub Potent
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