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Copaxone (December 05, 2012)
- Starting date:
- December 05, 2012
- Posting date:
- December 24, 2012
- Type of communication:
- Drug Recall
- Subcategory:
- Drugs
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-26181
Reason
Teva Canada initiated voluntary recall due to elevated number of customer complaints for visible presence of medical grade silicone oil essential in the syringe and plunger stopper system.
Depth of distribution
Recall to retail level - Distribution in Canada BC, AB, SK, MB, ON, QC, NS, NL.
Affected products
Copaxone
DIN, NPN, DIN-HIM
DIN 02245619
Dosage form
Solution
Strength
- 20 mg/mL
Lot or serial number
P53854
Companies
- Recalling Firm
- Teva Canada Ltd.
30 Novopharm Court
Toronto ON Ontario
Canada M1B 2K9
- Marketing Authorization Holder
- Not Applicable
- Date modified: