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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

Date modified: