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Health product recall

Apo-Napro-Na DS Tab 550mg (2016-12-02)

Starting date:
December 2, 2016
Posting date:
December 13, 2016
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-61452

Reason

Out of specification for dissolution during stability testing.

Depth of distribution

Wholesalers and retailers - Canada (AB, BC, NB, NF, ON, QC)

Affected products

Apo-Napro-Na DS Tab 550mg

DIN, NPN, DIN-HIM

DIN 01940309

Dosage form

Tablet

Strength

550 mg Naproxen Sodium

Lot or serial number

MK2992

Companies

Recalling Firm
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
Marketing Authorization Holder
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA