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Health product recall

Buckley's DM Decongestant

Starting date:
December 21, 2012
Posting date:
December 21, 2012
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-16861

Recalled Products

  1. Buckley's DM Decongestant

Reason

Product not meeting specification limits for Pseudoephedrine Hydrochloride through the stated shelf-life.

Depth of distribution

Wholesalers and retailers across Canada.

Affected products

A. Buckley's DM Decongestant

DIN, NPN, DIN-HIM
DIN 02052822
Dosage form

Liquid

Strength

Dextromethorphan Hydrobromide 12.5mg/5mL
Pseudoephedrine Hydrochloride 30mg/5mL

Lot or serial number

All Lots

Companies
Recalling Firm
Novartis Consumer Health Canada Inc. Suite 205, West Tower 2233 Argentia Road Mississauga, Ontario L5N 2X7
Marketing Authorization Holder
Novartis Consumer Health Canada Inc. Suite 205, West Tower 2233 Argentia Road Mississauga, Ontario L5N 2X7