PMS-Sulfasalazine product recall (2019-04-09)

Starting date:
April 9, 2019
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-69612

Last updated:

Summary

  • Product:
    1. PMS-Sulfasalazine 500 mg Tablet USP
    2. PMS-Sulfasalazine E.C. 500 mg Tablet

Reason

Only the units that have missing or unreadable lot number and/or expiration date are being recalled.

Depth of distribution

Retailers

Affected products

A. PMS-Sulfasalazine 500 mg Tablet USP

DIN, NPN, DIN-HIM

DIN 00598461

Dosage form

Tablet

Strength

Sulfasalazine 500 mg

Lot or serial number

All lots

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. PMS-Sulfasalazine E.C. 500 mg Tablet

DIN, NPN, DIN-HIM

DIN 00598488

Dosage form

Tablet (Enteric-Coated)

Strength

Sulfasalazine 500 mg

Lot or serial number

All lots

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