Drug Enforcement D-0007-2025

CGMP deviations

Status

Ongoing

Classification

Class II

Report Date

October 9, 2024

Termination Date

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Product Information

Product description
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
Product quantity
99 doses
Reason for recall
CGMP deviations
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
FL, MA, NJ, NY, PA, and VA

Location & Firm

Recalling firm
Advanced Accelerator Applications USA, Inc.
Address
57 E Willow St, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0007-2025
Event ID
95420
Recall initiation date
September 23, 2024
Center classification date
October 3, 2024
Code info
Lot#: LPS240919B-16, 24-Sep-2024 Lot#: LPS240920B-16, 25-Sep-2024 Lot#: LPS240920C-16, 25-Sep-2024
More code info
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