Health product recall

Pro Doc Irbesartan Product Recall (2019-03-11)

Starting date:
March 11, 2019
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-69330

Recalled Products

  1. Irbesartan 150mg Tablet
  2. Irbesartan 300mg Tablet

Reason

Affected lots manufactured with an API that contains the impurity N-nitrosodiéthylamine (otherwise known as “ndea”) above the acceptable level.

Depth of distribution

Retailers, Wholesalers

Affected products

A. Irbesartan 150mg Tablet

DIN, NPN, DIN-HIM

DIN 02365200

Dosage form

Tablet

Strength

Irbesartan 150mg

Lot or serial number

604292

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. Irbesartan 300mg Tablet

DIN, NPN, DIN-HIM

DIN 02365219

Dosage form

Tablet

Strength

Irbesartan 300mg

Lot or serial number

601795

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