Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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National Drug Code

Is NDC 54828-0001-50 recalled?

Neuraceq · 1 VIAL, MULTI-DOSE in 1 CONTAINER (54828-001-50) / 50 mL in 1 VIAL, MULTI-DOSE

Yes — this exact package was recalled

1 FDA recall names the code 54828-0001-50 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.

Active ingredient
Florbetaben F 18
Strength
FLORBETABEN F-18 135 mCi/mL
Form
Injection, Solution · Intravenous
Labeler
Lantheus Biosciences Ltd., a Lantheus company
Type
Human Prescription Drug
Product code
54828-0001

Recalls naming this package

Class II ยท Moderate risk

Florbetaben F-18

Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).

Terminated Sterility / contamination Sofie Co dba Sofie NDC 54828-001-50 D-1177-2023

Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.