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.
What this means for you
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.
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