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Health product recall

Gelnique

Starting date:
May 10, 2013
Posting date:
May 28, 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-33695

Recalled Products

  1. Gelnique

Reason

Product generated out of specification results for assay and viscosity upon shelf life/stability testing. Secondary product packaging (clamshell) was found to be applying pressure to the product primary packaging (pouch).

Depth of distribution

Distributed as samples to physicians to all provinces in Canada.

Affected products

A. Gelnique

DIN, NPN, DIN-HIM
DIN 02366150
Dosage form
  • Transdermal sachet, topical gel
Strength
  • 100 mg/g
Lot or serial number
  • 445683
  • 517844
Companies
Recalling Firm
The Watson Group
6500 Kitimat Road
Mississauga
L5N 2B8
Ontario
CANADA
Marketing Authorization Holder
Watson Laboratories, Inc.
575 Chipeta Way
Salt Lake City
84108
Utah
UNITED STATES

Date modified: