Class II Ongoing

Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufacturer Advanced Accelerator Applications, 57 E. Willow Street, NJ 07041, Millburn USA. NDC 69488-0010-61

Company: Advanced Accelerator Applications Usa, Inc.
Recall Initiated: September 23, 2024
Posted: October 9, 2024
Recall Number: D-0007-2025
Voluntary / Mandated: Voluntary: Firm initiated
Quantity: 99 doses
Firm Location: Millburn, NJ, United States

Reason for Recall

CGMP deviations

Distribution

FL, MA, NJ, NY, PA, and VA

FL MA NJ NY PA VA

Lot / Code Info

Lot#: LPS240919B-16, 24-Sep-2024 Lot#: LPS240920B-16, 25-Sep-2024 Lot#: LPS240920C-16, 25-Sep-2024

More recalls by Advanced Accelerator Applications Usa, Inc.

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