Health product recall

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

  1. Primidone 125 mg Tablet
  2. 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