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Health product recall

Polytopic Cream (2015-02-19)

Starting date:
February 19, 2015
Posting date:
February 24, 2015
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-43871

Recalled Products

Polytopic Cream

Reason

Product recalled due to Out of Specification result for the ingredient Polymixine B at 18 months stability testing.

Depth of distribution

Wholesalers

Affected products

Polytopic Cream

DIN, NPN, DIN-HIM
DIN 00422908
Dosage form

Cream

Strength

Gramicidine 0.25 mg/g
Polymyxine B 10000 unit/g

Lot or serial number

667906

Companies
Recalling Firm
Sandoz Canada Inc.
145 Jules-Léger
Boucherville
J4B 7K8
Quebec
CANADA
Marketing Authorization Holder
Sandoz Canada Inc.
145 Jules-Léger
Boucherville
J4B 7K8
Quebec
CANADA

Date modified: