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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
- 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