Status
Terminated
Drug Enforcement D-1085-2023
Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
Classification
Class III
Report Date
August 23, 2023
Termination Date
March 12, 2024
Product Information
- Product description
- 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
- Product quantity
- 10
- Reason for recall
- Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
- Recall initiation reason
- —
- Initial firm notification
- —
- Distribution pattern
- Distributed Nationwide in the USA
Location & Firm
- Recalling firm
- Advanced Accelerator Applications USA, Inc.
- Address
-
57 E Willow St
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1085-2023
- Event ID
- 92845
- Recall initiation date
- August 7, 2023
- Center classification date
- August 15, 2023
- Code info
- Lot # LPS230729B-16, Exp 8/3/2023 at 10:00am, LPS230804B-16, Exp 8/9/2023 at 10:00am.
- More code info
- —