FDA Drug recall D-1085-2023
PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL Single-dose vial, Manufacturer: Advanced Accelera…
- FDA Drug
- Class III
- terminated
- Published 2023-08-23
On 2023-08-23 the FDA classified a Class III recall of PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL Single-dose vial, Manufacturer: Advanced Accelera… by Advanced Accelerator Applications Usa, citing labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1085-2023 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2023-08-07 |
| Published | 2023-08-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Advanced Accelerator Applications Usa |
| Distribution | US |
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
Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
Identifiers
| code_info | Lot # LPS230729B-16, Exp 8/3/2023 at 10:00am, LPS230804B-16, Exp 8/9/2023 at 10:00am. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1085-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.