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Health product recall

NDarvon-N

Starting date:
January 1, 2011
Posting date:
December 20, 2010
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Unacceptable risk to health
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-2010A271

Recalled products

  1. NDarvon-N

Reason

Paladin has decided to recall all lots of NDarvon-N® (dextropropoxyphene, also known as propoxyphene) on the Canadian market and discontinue the sale of the product following the US FDA request for withdrawal of all propoxyphene containing products due to new data showing that the drug can cause serious toxicity to the heart, even when used at therapeutic doses. FDA concluded that the safety risks of propoxyphene products outweigh its benefits for pain relief at recommended doses.

Depth of distribution

Wholesalers and pharmacies across Canada

Affected products

NDarvon-N

DIN, NPN, DIN-HIM
DIN 00261432
Dosage form
  • Capsules
Strength
  • 100 mg
Lot or serial number
  • 448607
  • 445947
Companies
Recalling Firm
Paladin Labs Inc. / Distributor 6111 Royalmount Ave., Suite 102 Montreal, Quebec H4P 2T4
Marketing Authorization Holder
Paladin Labs Inc. 6111 Royalmount Ave., Suite 102 Montreal, Quebec H4P 2T4
Recalling Firm
Paladin Labs Inc. / Distributor
6111 Royalmount Ave., Suite 102
Montreal
H4P 2T4
Quebec
CANADA
Marketing Authorization Holder
Paladin Labs Inc. / Distributor
6111 Royalmount Ave., Suite 102
Montreal
H4P 2T4
Quebec
CANADA

Date modified: