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Cyclodx: out of specification test results

Official notice

6 Nov 2025

Last checked

6 Nov 2025

Low riskHealth Canada

An official Health Canada notice concerns Cyclodx: out of specification test results. The target irradiation time for the production of the active ingredient Fludeoxyglucose 18F is out of specification for the affected lot. Published 2025-11-06.

What to do now

Verify if your product is affected. Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns. Contact the recalling firm if you have any questions about the recall. Report any health product related side effects to Health Canada. Report any other health product safety complaints to Health Canada.

Recall number

78455

Official notice

2025-11-06

The hazard

The target irradiation time for the production of the active ingredient Fludeoxyglucose 18F is out of specification for the affected lot.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

78455

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Affected products

Product 1

Brand - CYCLODX, Product Name - CYCLODX, Market Authorization - DIN 02462958, Dosage Form - Solution, Strength - FLUDEOXYGLUCOSE 18F 7.4 GBQ / ML, Lot - FDG251031-02

Risk / hazard

The target irradiation time for the production of the active ingredient Fludeoxyglucose 18F is out of specification for the affected lot.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Manufacturer

Not provided

Phone

Not provided

Brand: Cyclodx.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type III

App estimate

low

Recall details

Recall number

78455

Classification

Type III

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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