Advanced Accelerator Applications recalls NETSPOT kits for Ga 68 dotatate injection due to low out-of-specification results in stability testing. Affected kits contain specific vial and lot numbers with expiration dates through March 2022.
Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
Advanced Accelerator Applications is recalling NETSPOT kits for Ga 68 dotatate injection because stability testing showed low out-of-specification results for Vial 1. This could lead to incorrect dosing if used in medical procedures.
The kit contains a component that failed stability testing, resulting in lower-than-expected drug concentration. This could cause incorrect dosing during medical procedures if the kit is used without proper verification.
Healthcare professionals using NETSPOT kits for nuclear medicine procedures are affected. Patients receiving the injection may be at risk if the kit is used incorrectly.
Check for NETSPOT kits with vial lot numbers F03221004 to F03221007 and expiration dates through March 2022. The kits include specific product codes like PG1921014 to PG1921021.
Verify the expiration date on the kit label; affected kits expire by March 2022.
Reach out to Advanced Accelerator Applications for specific guidance on affected kits.
The kits contain Vial 1 with low out-of-specification results from stability testing, which could lead to incorrect dosing in medical procedures.
Check for lot numbers F03221004 to F03221007 and expiration dates through March 2022 on the kit label.
The recall indicates a low risk of incorrect dosing, so immediate action is not required but verification is recommended.
We’ve drafted a message you can send Advanced Accelerator Applications to request your refund or repair — edit it as you like.
Subject: Recall D-0747-2022 — Advanced Accelerator Applications Advanced Accelerator Applications Hello, I own a Advanced Accelerator Applications that is covered by recall D-0747-2022 from Advanced Accelerator Applications. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
