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Health product recall

APRI 21

Starting date:
April 3, 2013
Posting date:
April 23, 2013
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-26851

Recalled Products

  1. APRI 21

Reason

Impurity identified as N-Butylbenzenesulfonamide (NBBS) detected during stability testing of the product.

Depth of distribution

Wholesalers/Distributors and Retail/Pharmacy in all provinces and Nunavut

Affected products

A. APRI 21

DIN, NPN, DIN-HIM
DIN 02317192
Dosage form
  • Film Coated Tablet
Strength
  • 150 mcg / 30 mcg
Lot or serial number
  • 33802977A
  • 33802976A
Companies
Recalling Firm
Apotex Inc.
4100 Weston Road
Toronto
M9L 2Y6
Ontario
CANADA
Marketing Authorization Holder
Barr Laboratoires Inc.
223 Quaker Road
Pomona
10970-0519
New York
UNITED STATES