Primidone Tablet
- Starting date:
- April 5, 2018
- Type of communication:
- Drug Recall
- Subcategory:
- Drugs
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-66458
Recalled Products
- Primidone 125 mg Tablet
- Primidone 250 mg Tablet
Reason
The product lot did not meet the Permissible Daily Exposure (PDEs) limit for Lead (Pb).
Depth of distribution
BC, AB, SK, MB, ON, QC, NS, NF
Affected products
A) Primidone 125 mg Tablet
DIN, NPN, DIN-HIM
DIN 00399310
Dosage form
Tablet
Strength
125 mg
Lot or serial number
MT4040
Companies
- Recalling Firm
-
AA Pharma Inc.
1-1165 Creditstone Road
Thornhill
L4K 4N7
CANADA
- Marketing Authorization Holder
-
AA Pharma Inc.
1-1165 Creditstone Road
Thornhill
L4K 4N7
CANADA
B) Primidone 250 mg Tablet
DIN, NPN, DIN-HIM
DIN 00396761
Dosage form
Tablet
Strength
250 mg
Lot or serial number
MM3274
Companies
- Recalling Firm
-
AA Pharma Inc.
1-1165 Creditstone Road
Thornhill
L4K 4N7
CANADA
- Marketing Authorization Holder
-
AA Pharma Inc.
1-1165 Creditstone Road
Thornhill
L4K 4N7
CANADA