PLUVICTO 1 — Class III drug recall D-1085-2023
Terminated recall by Advanced Accelerator Applications USA, Inc., reported 2023-08-23, distributed nationwide. Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expir
| Recall number | D-1085-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Accelerator Applications USA, Inc., Millburn, NJ, United States |
| Recall initiated | 2023-08-07 |
| Classified | 2023-08-15 |
| Reported by FDA | 2023-08-23 |
| Terminated | 2024-03-12 |
| Distributed | Nationwide (US) |
| Quantity | 10 |
| Reason classes | labeling |
| NDC | 69488-0010-61 |
| Lot numbers | LPS230729B-16, LPS230804B-16 |
| Expiration dates | 2023-08-03, 2023-08-09 |
Product
PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL Single-dose vial, Manufacturer: Advanced Accelerator Appllications USA, Inc., 57 E. Willow Street NJ 07041, Milburn, USA, NDC 69488-010-61
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1085-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.