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Health & beauty Canada Health product recall

CYCLODX: Out of Specification Test Results

CYCLODX solution (Fludeoxyglucose 18F 7.4 GBq/mL), DIN 02462958, lot FDG251031-02, distributed by CIUSS de l’Estrie – Centre hospitalier universitaire de Sherbrooke, is affected. It was recalled because the target irradiation time for production of the active ingredient Fludeoxyglucose 18F is out of specification; verify if your product is affected, consult your healthcare provider before discontinuing use, contact the recalling firm with questions, and report any side effects or other safety complaints to Health Canada.

What's being recalled

Depth of Recall: Health Care Establishments

Companies: CIUSS DE L'ESTRIE - CENTRE HOSPITALIER UNIVERSITAIRE DE SHERBROOKE, 3001, 12eme Avenue Nord, Sherbrooke, Quebec, Canada, J1H 5N4.

How to identify it

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

The hazard

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

What to do

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.

The official notice

This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.

Read the official notice (opens in a new tab)

A little guidance

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