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Health product recall

Venomil Wasp Venom Protein 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-34741

Recalled products

  1. Venomil Wasp Venom Protein (120 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 Wasp Venom Protein (120 mcg)

DIN, NPN, DIN-HIM
DIN 02226219
Dosage form

Powder for solution (Venomil Wasp Venom Protein 120 mcg).

Strength

Wasp venom protein 120 mcg / vial

Lot or serial number
  • D31619B
  • A1300029
  • M31619A
  • A1200009
  • A1200115
  • A1200008
  • A1200096
  • A1300068
  • M29636A
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
  • D31619B
  • A1300029
  • M31619A
  • A1200009
  • A1200115
  • A1200008
  • A1200096
  • A1300068
  • M29636A
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