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Health product recall

Buscopan Tablets 10 mg (2014-10-02)

Starting date:
October 2, 2014
Posting date:
October 10, 2014
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-41757

Recalled products

Buscopan Tablets 10 mg

Reason

Out Of Specification dissolution result obtained during routine stability studies.

Note: only product in blisters is affected, not product in bottles.

Depth of distribution

Wholesalers and retailers

Affected products

Buscopan Tablets 10 mg

DIN, NPN, DIN-HIM

DIN 00363812

Dosage form

Tablet

Strength

10 mg

Lot or serial number

357910

357911

357912

357913

358421

454157

358421R

359049

359050

359051

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