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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