DermOtic Oil Ear Drops (2021-05-25)

Starting date:
May 25, 2021
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-75709

Last updated:

Summary

  • Product: DermOtic Oil Ear Drops

Reason

Presence of broken glass in the glass pipette of the ear dropper.

Depth of distribution

Retailers, 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

  • 19K036E
  • 19L039D
  • 20A001D
  • 20A003F
  • 20A003G
  • 20C013F
  • 20E025E
  • 20G037D
  • 20H041G
  • 20J043G
  • 20K050E
  • 20L055F
  • 20L055H
  • 21C015D
  • 21C018F

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