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Health product recall

Apo-Oxycodone CR (2013-10-28)

Starting date:
October 28, 2013
Posting date:
November 21, 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-36693

Recalled products

A. Apo-Oxycodone CR 

Reason

High out of specification dissolution testing result at the 9-month time point.

Depth of distribution

Product distributed to Canadian market.

Affected products

Apo-Oxycodone CR

DIN, NPN, DIN-HIM
DIN 02394774
Dosage form

Controlled-Release Tablets

Strength
  • 30 mg
Lot or serial number
  • KF3103
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

Date modified: