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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