This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
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
- 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