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Health product recall

Venomil Mixed Vespid Venom Kit

Starting date:
July 12, 2013
Posting date:
July 30, 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-34743

Recalled products

  1. Venomil Mixed Vespid Venom (360 mcg)
  2. Diluent for Allergenic Extract Sterile Albumin Saline with phenol

Reason

After a delamination issue, glass particles were found during the 18 month stability test in the "Diluent for Allergenic Extract Sterile Albumin Saline with Phenol" which is packaged in this kit.

Depth of distribution

Wholesalers, pharmacies, hospitals and doctors in Canada

Affected products

A. Venomil Mixed Vespid Venom (360 mcg)

DIN, NPN, DIN-HIM
DIN 02226294
Dosage form
  • Powder for solution (Venomil Mixed Vespid Venom)
Strength
  • Venom protein of yellow hornet 120 mcg / vial
  • Venom protein of white headed hornet 120 mcg / vial
  • Wasp venom protein 120 mcg / vial
Lot or serial number
  • A1200020
  • M27840A
  • A1200075
  • A1300027
  • M27840B
  • M30396A
  • M31296A
Companies
Recalling Firm
Omega Laboratories Ltd.
11, 177 Hamon St.
Montreal
H3M 3E4
Quebec
CANADA
Marketing Authorization Holder
Omega Laboratories Ltd.
11, 177 Hamon St.
Montreal
H3M 3E4
Quebec
CANADA

B. Diluent for Allergenic Extract Sterile Albumin Saline with phenol

DIN, NPN, DIN-HIM
DIN 02223732
Dosage form
  • Liquid (Diluent for Allergenic Extract Sterile Albumin Saline with phenol)
Strength
  • Albumin (Human) - 0.03%
Lot or serial number
  • A1200020
  • M27840A
  • A1200075
  • A1300027
  • M27840B
  • M30396A
  • M31296A
Companies
Recalling Firm
Omega Laboratories Ltd.
11, 177 Hamon St.
Montreal
H3M 3E4
Quebec
CANADA
Marketing Authorization Holder
Omega Laboratories Ltd.
11, 177 Hamon St.
Montreal
H3M 3E4
Quebec
CANADA

Date modified: