September 2024 FDA Recall Drug by Advanced Accelerator Applications Usa, Inc.
D-0007-2025 - CGMP deviations
This Class II drug recall was voluntarily initiated by Advanced Accelerator Applications Usa, Inc. on September 23, 2024 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in FL, MA, NJ, NY, PA, and VA and the recall is currently ongoing.
Recall Number: D-0007-2025
CGMP deviations
09-23-2024
10-09-2024
99 doses
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Advanced Accelerator Applications USA, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
FL, MA, NJ, NY, PA, and VA
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# : LPS240919B-16, 24-Sep-2024
Lot# : LPS240920B-16, 25-Sep-2024
Lot# : LPS240920C-16, 25-Sep-2024
