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Health product recall

PMS-REPAGLINIDE 0.5, 1, 2 mg (2017-04-18)

Starting date:
April 18, 2017
Posting date:
June 22, 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-63718

Affected products

  1. pms-REPAGLINIDE 0.5 mg
  2. pms-REPAGLINIDE 1 mg
  3. pms-REPAGLINIDE 2 mg

Reason

Out of specification for degradation product during stability program

Depth of distribution

Retailers across Canada

Affected products

  1. pms-REPAGLINIDE 0.5 mg

DIN, NPN, DIN-HIM

DIN 02354926

Dosage form

Tablet

Strength
  • 0.5 mg Repaglinide
Lot or serial number
  • 1505633
  • 1603268
  • 1605206
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. 1 mg Repaglinide

DIN, NPN, DIN-HIM

DIN 02354934

Dosage form

Tablet

Strength

1 mg Repaglinide

Lot or serial number

1503616

1503618

1505152

1600517

1603267

1604366

1606629

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



2 mg Repaglinide

DIN, NPN, DIN-HIM

DIN 02354942

Dosage form

Tablet

Strength

2 mg Repaglinide

Lot or serial number

1503758

1504583

1504616

1505216

1600541

1601138

1603373

1603868

1605207

1606633

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


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