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Health product recall

Hill Dermaceuticals Product Recall (2017-01-05)

Starting date:
January 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-68772

Recalled Products

  1. Dermotic Oil Ear drops
  2. Derma Smoothe / FS Liq 0.01%

Reason

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

Depth of distribution

Wholesalers

Affected products

A. Dermotic Oil Ear drops

DIN, NPN, DIN-HIM

DIN 02300559

Dosage form

Solution

Strength

Fluocinolone acetonide 0.01% / w/v

Lot or serial number

16B008D

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



B. Derma Smoothe / FS Liq 0.01%

DIN, NPN, DIN-HIM

DIN 00873292

Dosage form

Emulsion

Strength

Fluocinolone acetonide 0.01% / w/v

Lot or serial number

16A002F, 16B009A

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