Reported Apr 13, 2022 · Terminated
NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, kit contains Vial 1 (Reaction vial with…
Advanced Accelerator Applications USA, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Advanced Accelerator Applications USA, Inc. · 57 E Willow St · Millburn, NJ · 07041-1416
Is this the product you have?
- 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 forAdvanced Accelerator Applications USA, Inc
- byGipharma S.r.l., Strada Crescentino snc, 13040 Saluggia (Vc), Italy, NDC 69488-001-40
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 (F03221004 vial) in kit PG1921014, PG1921015, Exp 16-Mar-2022 2 (F03221005 vial) in kit PG1921016, PG1921017, Exp 18-Mar-2022 3 (F03221006 vial) in kit PG1921018, PG1921019, Exp 11-May-2022 4 (F03221007 vial) in kit PG1921020, PG1921021, Exp 04-Aug-2022 - Amount recalled
- 14,089 kits
Where it was sold
- Nationwide
- PR
Why it was recalled
Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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