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Health & beauty Canada Health product recall

DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION, USP: Out of Specification Test Result

Baxter Corporation DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION, USP (solution) 100 mcg/mL, DIN 02513978, lot A0H0665 is affected; sold in Alberta, British Columbia, Ontario, Quebec, Saskatchewan and Yukon. The lot was recalled because the chromatographic purity assay 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 to Health Canada.

What's being recalled

Depth of Recall: Health Care Establishments

Companies: Baxter Corporation, 7125 Mississauga Road, Mississauga, ON, L5N 0C2.

How to identify it

Brand: Baxter; Product Name: DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION, USP; Market Authorization: DIN 02513978; Dosage Form: Solution; Strength: DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100mcg/ml; Lot: A0H0665

The hazard

The chromatographic purity assay is out of specification in 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.

Where it was sold

Alberta, British Columbia, Ontario, Quebec, Saskatchewan, Yukon

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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