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Health product recall

Pro-Derm SPF Recall (2014-10-27)

Starting date:
October 27, 2014
Posting date:
November 6, 2014
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-42119

Recalled Products

A. Pro-Derm SPF 20 Daytime Fluid

B. Pro-Derm SPF 60

Reason

The lot does not meet the stability specifications for avobenzone content.

Depth of distribution

Retailers

Affected products

A. Pro-Derm SPF 20 Daytime Fluid

DIN, NPN, DIN-HIM
DIN 02247760
Dosage form

Gel

Strength

Avobenzone 3%
Titanium Dioxide 0.75%
Octinoxate 1.05%
Octocrylene 3%

Lot or serial number

17591

Companies
Recalling Firm
Valeant Cosméderme
2805 Place Louis R Renaud
Laval
H7V 0A3
Quebec
CANADA
Marketing Authorization Holder
Valeant Cosméderme
2805 Place Louis R Renaud
Laval
H7V 0A3
Quebec
CANADA

B. Pro-Derm SPF 60

DIN, NPN, DIN-HIM
DIN 02283506
Dosage form

Cream

Strength

Avobenzone 3%
Titanium Dioxide 3.75%
Octinoxate 7.5%
Octocrylene 10%
Zinc Oxide 0.45%

Lot or serial number

16251

Companies
Recalling Firm
Valeant Cosméderme
2805 Place Louis R Renaud
Laval
H7V 0A3
Quebec
CANADA
Marketing Authorization Holder
Valeant Cosméderme
2805 Place Louis R Renaud
Laval
H7V 0A3
Quebec
CANADA