Class II · Moderate risk
Kit for the Preparation of Technetium Tc 99m Sestamibi Injection
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
NETSPOT (kit for the preparation of Ga 68 dotatate injection) (68ga-Dotatate)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
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
Affected NDC
69488-0001-40
Compare with the code on your package — it is the most precise check available.
Drug: Mannitol
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Netspot 68Ga-DOTATATE NDC 69488-0001 |
Kit Intravenous |
Advanced Accelerator Applications USA, Inc | Rx |
- Recalling firm
- Advanced Accelerator Applications USA, Inc.
- NDC code
- 69488-001-40
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0747-2022 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Mannitol recalls
See all
Class II · Moderate risk
Cardioplegia Solution del Nido Formula
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
Cardioplegia Solution del Nido Formula
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg
Super Potent and Failed Reconstitution Time
Class III · Low risk
Sb-4
Sub Potent
Other recalls by Advanced Accelerator Applications USA, Inc.
All 2022 recalls
Class II · Moderate risk
Pluvicto
CGMP deviations
Class III · Low risk
Pluvicto 1
Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
Class II · Moderate risk
Netspot
Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
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