Class II · Moderate risk
Pluvicto
CGMP deviations
Netspot (68ga-Dotatate)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only, 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.
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-0799-2020 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Advanced Accelerator Applications USA, Inc.
All 2020 recalls
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 III · Low risk
NETSPOT (kit for the preparation of Ga 68 dotatate injection)
Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
Other packaging defect recalls from 2020
All packaging defect recalls
Class II · Moderate risk
Levetiracetam Oral Solution
Defective container: Customer complaints for oral solution leaking from bottles.
Class III · Low risk
Desflurane
DEFECTIVE CONTAINER: Desflurane Liquid for Inhalation 240 mL may be leaking.
Class II · Moderate risk
Albuterol Sulfate Inhalation Aerosol
Defective Delivery System: Sustained trend of failure to dispense complaints.
Class II · Moderate risk
Cetrotide (cetrorelix acetate for Injection)
Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance.
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