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Health product recall

Spiriva (2013-10-07)

Starting date:
October 7, 2013
Posting date:
July 25, 2014
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-40745

Recalled Products

Spiriva

Reason

Drug substance material used to make drug product lots may be contaminated with extrinsic foreign particles.

Depth of distribution

Wholesalers across Canada

Affected products

Spiriva

DIN, NPN, DIN-HIM
DIN 02246793
Dosage form

Capsule

Strength

18 μg tiotropium (22.5 μg tiotropium bromide monohydrate) per capsule

Lot or serial number
  • 107625
  • 108319A
  • 108363
  • 108319
  • 108972
  • 108536
  • 108275
  • 108915
  • 108362A
  • 107976
  • 201181
  • 107625
  • 108541
  • 107625A
  • 108485
  • 201182
  • 108914
  • 201052
  • 107715
  • 201054
  • 204087
Companies
Recalling Firm
Boehringer Ingelheim (Canada) Ltd.
5180 South Service Road
Burlington
L7L 5H4
Ontario
CANADA
Marketing Authorization Holder
Boehringer Ingelheim (Canada) Ltd.
5180 South Service Road
Burlington
L7L 5H4
Ontario
CANADA