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Health product recall

pms-REPAGLINIDE (2017-04-04)

Starting date:
April 4, 2017
Posting date:
April 19, 2017
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-63042

Affected Products

A. pms-REPAGLINIDE 0.5 mg

B. pms-REPAGLINIDE 1 mg

Reason

Out of specification for degradation product during stability testing in affected lot.

Depth of distribution

Retailers across Canada

Affected products

A. pms-REPAGLINIDE 0.5 mg

DIN, NPN, DIN-HIM

DIN 02354926

Dosage form

Tablet

Strength

0.5 mg

Lot or serial number
  • 1504536
  • 1600499
Companies
Recalling Firm

Pharmascience Inc.

100, 6111 Royalmount Avenue

Montreal

H4P 2T4

Quebec

CANADA

Marketing Authorization Holder

Pharmascience Inc.

100, 6111 Royalmount Avenue

Montreal

H4P 2T4

Quebec

CANADA


B. pms-REPAGLINIDE 1 mg

DIN, NPN, DIN-HIM

DIN 02354934

Dosage form

Tablet

Strength

1 mg

Lot or serial number
  • 1601071
Companies
Recalling Firm

Pharmascience Inc.

100, 6111 Royalmount Avenue

Montreal

H4P 2T4

Quebec

CANADA

Marketing Authorization Holder

Pharmascience Inc.

100, 6111 Royalmount Avenue

Montreal

H4P 2T4

Quebec

CANADA