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Dermaflex HC 1% Cream (May 14, 2009)

Starting date:
May 14, 2009
Posting date:
June 22, 2009
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-2009A70

Reason

The Hydrocortisone acetate did not support a 36 months shelf-life when stored at World Health Organization specifications 250C± 20C. At 18 months, one lot recorded reaches a lower potency for Hydrocortisone acetate.

Depth of distribution

Wholesalers and pharmacies in Canada only. No export.

Affected products

Dermaflex HC 1% Cream

DIN, NPN, DIN-HIM

DIN 00681989

Dosage form

Cream

Strength

  • Hydrocortisone acetate 1%

Lot or serial number

R1021, P0811

Companies

Recalling Firm
Neolab Inc. (Distributor)
5476 Upper Lachine Road
Montreal Quebec
Canada H4A 2A4
Marketing Authorization Holder
Neolab Inc. (Distributor)
5476 Upper Lachine Road
Montreal Quebec
Canada H4A 2A4