Advanced Accelerator Applications USA, Inc. 2022-04-13 Health moderate FDA
Health · FDA · Recall #FDA-D-0747-2022
NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, kit… Recall
Issued April 13, 2022 · Advanced Accelerator Applications USA, Inc.
In April 2022, Advanced Accelerator Applications USA, Inc. recalled the NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, kit…, a moderate health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
What you should do
- 1 Stop using NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, kit… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Advanced Accelerator Applications USA, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Advanced Accelerator Applications USA, Inc.
- Category
- Health
- Recall date
- April 13, 2022
- Units affected
- Not reported
- Sold at
- Nationwide in the USA and Puerto Rico
- Recall number
- FDA-D-0747-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Advanced Accelerator Applications USA, Inc. has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.