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
Reported: October 9, 2024 Initiated: September 23, 2024 #D-0007-2025
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
Reason for Recall
CGMP deviations
Details
- Recalling Firm
- Advanced Accelerator Applications USA, Inc.
- Units Affected
- 99 doses
- Distribution
- FL, MA, NJ, NY, PA, and VA
- Location
- Millburn, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Advanced Accelerator Applications USA, Inc.. Units affected: 99 doses.
Why was this product recalled? ▼
CGMP deviations
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 9, 2024. Severity: Moderate. Recall number: D-0007-2025.
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