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pms-Betahistine (2016-05-12)
- Starting date:
- May 12, 2016
- Posting date:
- May 24, 2016
- Type of communication:
- Drug Recall
- Subcategory:
- Drugs
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Hospitals, Healthcare Professionals
- Identification number:
- RA-58558
Affected products
pms-Betahistine
Reason
Labelling error. The dosage on the carton (1/2 to 1 tablet three times daily) could result in exceeding the maximum daily dose of 48mg.
Depth of distribution
Wholesalers and pharmacies in Canada
Affected products
pms-Betahistine
DIN, NPN, DIN-HIM
DIN 2330237
Dosage form
Tablet
Strength
24 mg
Lot or serial number
1410266A
1504098A
Companies
- Recalling Firm
-
Pharmascience Inc.
100, 6111 Royalmount Avenue
Montreal
H4P 2T4
Quebec
CANADA
- Marketing Authorization Holder
-
Pharmascience Inc.
100, 6111 Royalmount Avenue
Montreal
H4P 2T4
Quebec
CANADA