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Invega Sustenna (February 09, 2011)

Report a Concern
Starting date:
February 09, 2011
Posting date:
March 07, 2011
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-2011A41

Reason

As a result of blue dye ingress testing on 1.5 ml filled and labelled syringes, a crack in the syringe barrel was identified. The crack is covered and is not visible without removing the syringe label. A product defect has been revealed in the course of stability monitoring testing.

Depth of distribution

Distributed to wholesalers, retailers, hospitals, doctor's offices and clinics. In Canada distributed in Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland, Nova Scotia, Ontario, Quebec and Saskatchewan.

Affected products

Invega Sustenna

DIN, NPN, DIN-HIM

DIN 02354241

Dosage form

Sterile injectable

Strength

  • 150 mg Paliperidone Palmitate

Lot or serial number

9HBK000

Companies

Recalling Firm
Janssen Inc.,
19 Green Belt Drive,
Toronto Ontario
Canada M3C 1L9
Marketing Authorization Holder
Janssen Inc.,
19 Green Belt Drive,
Toronto Ontario
Canada M3C 1L9