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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

Date modified: