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Health product recall

Dermotic Oil Ear drops (2017-03-05)

Starting date:
March 5, 2017
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-68774

Recalled Products

Dermotic Oil Ear drops

Reason

The medicinal ingredient (fluocinolone acetonide) may be out of specification in the affected lot(s).

Depth of distribution

Wholesalers

Affected products

Dermotic Oil Ear drops

DIN, NPN, DIN-HIM
DIN 02300559
Dosage form

Solution

Strength

Fluocinolone acetonide 0.01% / w/v

Lot or serial number

16C012B

Companies
Recalling Firm
Hill Dermaceuticals Inc.
3045 Southcreek Road, Unit 4
Mississauga
L4X 2X6
Ontario
CANADA
Marketing Authorization Holder
Hill Dermaceuticals Inc.
3045 Southcreek Road, Unit 4
Mississauga
L4X 2X6
Ontario
CANADA

Date modified: