Advanced Accelerator Applications USA, Inc.

Complete recall history across all FDA and CPSC categories — 4 total recalls

Advanced Accelerator Applications USA, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (4)

FDA drug safety enforcement actions by Advanced Accelerator Applications USA, Inc.

Date Product Reason Class
Sep 23, 2024 Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan in... CGMP deviations Class II
Aug 7, 2023 PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injec... Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with t... Class III
Mar 18, 2022 NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate... Subpotent Drug: low out-of-specification results for Vial 1 assay obtained d... Class III
Jan 10, 2020 NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatat... Defective Container: loose aluminum cap crimp for the dilution buffer vial pr... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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