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Health product recall

REPAGLINIDE 0.5, 1, 2 mg (2017-04-21)

Starting date:
April 28, 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-63720

Affected Products

  1. REPAGLINIDE 0.5 mg
  2. REPAGLINIDE 1 mg
  3. REPAGLINIDE 2 mg

Reason

Out of specification for degradation product during stability program

Depth of distribution

Retailers across Quebec

Affected products

  1. REPAGLINIDE 0.5 mg

DIN, NPN, DIN-HIM

DIN 02415968

Dosage form

Tablet

Strength

1 mg Repaglinide

Lot or serial number
  • 1505632
  • 1603270
  • 1603271
Companies
Recalling Firm

Pro Doc Ltd.

2925 Industrial Blvd.

Laval

H7L 3W9

Quebec

CANADA

Marketing Authorization Holder

Pro Doc Ltd.

2925 Industrial Blvd.

Laval

H7L 3W9

Quebec

CANADA



B. REPAGLINIDE 1 mg

DIN, NPN, DIN-HIM

DIN 02415976

Dosage form

Tablet

Strength

REPAGLINIDE 1 mg

Lot or serial number

1600516

1603272

1604375

Companies
Recalling Firm

Pro Doc Ltd.

2925 Industrial Blvd.

Laval

H7L 3W9

Quebec

CANADA

Marketing Authorization Holder

Pro Doc Ltd.

2925 Industrial Blvd.

Laval

H7L 3W9

Quebec

CANADA



REPAGLINIDE 2 mg

DIN, NPN, DIN-HIM

DIN 02415984

Dosage form

Tablet

Strength

2 mg Repaglinide

Lot or serial number

1600540

1603875

Companies
Recalling Firm

Pro Doc Ltd.

2925 Industrial Blvd.

Laval

H7L 3W9

Quebec

CANADA

Marketing Authorization Holder

Pro Doc Ltd.

2925 Industrial Blvd.

Laval

H7L 3W9

Quebec

CANADA