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Health product recall

Biacna Topical Gel

Starting date:: June 27, 2013
Posting date:: July 17, 2013
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-34667

Reason
Depth of distribution
Affected products

Recalled products

Biacna Topical Gel

Reason

Out of specification results obtained for assay on a three month stability sample for lot 78843.

Depth of distribution

Samples directly distributed to doctors in Canada.

Affected products

A. Biacna Topical Gel

DIN, NPN, DIN-HIM

DIN 02359685

Dosage form

Gel

Strength

Clindamycin phosphate 1.2%
Tretinoin 0.025%

Lot or serial number

78843

Companies

Recalling Firm

Valeant Canada LP

2150 St-Elzear Boulevard West,

Laval

H7L 4A8

Quebec

CANADA

Marketing Authorization Holder