FDA Recalls NETSPOT Kits Due to Defective Aluminum Cap Crimp
Advanced Accelerator Applications USA, Inc. is recalling NETSPOT kits because the dilution buffer vial has a loose aluminum cap crimp.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The defect is a packaging issue (loose cap crimp) with no reported illnesses or injuries, fitting the criteria for a moderate severity recall involving minor labeling or packaging errors.
Plain-English summary
Advanced Accelerator Applications USA, Inc. is recalling 4,295 kits of NETSPOT (68GA-DOTATATE) for intravenous use. The recall was initiated because the dilution buffer vial (vial 2) in the kit has a defective container, specifically a loose aluminum cap crimp.
The affected product is NETSPOT, a kit for the preparation of Ga 68 dotatate injection, 40 mcg dotatate. The kits were distributed nationwide in the US and Canada. The specific lots involved are PG1919025 (expiration 07/11/2020), PG1919026, and PG1919027 (expiration 07/16/2020).
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product matches the description, it should be removed from use and returned to the distributor or manufacturer per the recall instructions.
The recalled product
- Product
- NETSPOT (68GA-DOTATATE)
- Brand
- NETSPOT
- Manufacturer
- Advanced Accelerator Applications USA, Inc.
- Category
- Drug — Radiopharmaceutical
- Hazard
- Affected units
- 4,295
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot #: PG1919025
- Exp. 07/11/2020
- PG1919026
- PG1919027
- Exp. 07/16/2020.
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · NETSPOT
- ModerateNETSPOT prescription drug kit recalled for subpotency in vial 1
FDA (Drugs) · 2022-04-13
Same manufacturer · Advanced Accelerator Applications USA, Inc.
See all →- HighPluvicto Radiopharmaceutical Drug Recalled Due to Manufacturing Quality Deviations
FDA (Drugs) · 2024-10-09
- ModeratePLUVICTO Injection Recalled for Incorrect Lot and Expiration Date Labels
FDA (Drugs) · 2023-08-23
Same hazard · packaging defect
See all →- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- HighCardinal Health Recalls Presource Convenience Kits Due to Seal Defects
FDA (Devices) · 2026-09-30
- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighCardinal Health Recalls Presource Convenience Kits Due to Potential Seal Defects
FDA (Devices) · 2026-09-30
Similar recalls
- ModerateNETSPOT prescription drug kit recalled for subpotency in vial 1
FDA (Drugs) · 2022-04-13
- ModerateAmerican Health Packaging Recalls Benzonatate Capsules Due to Wet Capsule Reports
FDA (Drugs) · 2015-04-08
- ModerateFenofibrate Capsules 200 mg Recalled for CGMP Manufacturing Deviations
FDA (Drugs) · 2026-07-01
- HighPluvicto Radiopharmaceutical Drug Recalled Due to Manufacturing Quality Deviations
FDA (Drugs) · 2024-10-09
- HighAbbVie Recalls Lupron Depot Kits Due to Defective Needle Protection Device
FDA (Drugs) · 2014-05-07
- ModerateJubilant Draximage Recalls DRAXIMAGE DTPA Kits Due to Stability Failures
FDA (Drugs) · 2020-04-01