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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