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Health product recall

Extra Strength Daytime Flu Relief - Rexall, Selection, and Option +

Starting date:
July 22, 2013
Posting date:
August 2, 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-34815

Recalled products

  1. Rexall Extra Strength Flu Relief Daytime
  2. Selection Extra Strength Flu Relief Daytime
  3. Option+ Extra Strength Flu Relief Daytime

Reason

Rexall and Option +:

The following caution statement is missing in French:

"Evitez la consommation d’alcool quand vous utilisez ce produit"

Selections :

The following caution statements are missing in French:

"Evitez la consommation d’alcool quand vous utilisez ce produit"

AND

"Au cours des 24 premières heures vous pouvez ressentir une transpiration excessive, des nausées, des vomissements, des douleurs a l’estomac et une perte d’appetit."

Depth of distribution

Distributed to the retail level. Nationally in Canada only.

Affected products

A. Rexall Extra Strength Flu Relief Daytime

DIN, NPN, DIN-HIM
DIN 02248580
Dosage form
  • Caplet
Strength
  • Dextromethorphan Hydrobromide, 15 mg
  • Pseudoephedrine Hydrochloride, 30 mg
  • Acetaminophen, 500 mg
Lot or serial number
  • 2C1332NEV
  • 1I1123FM8
  • 1G1062CKX
  • 0I12729GB
  • 0I12726MR
Companies
Recalling Firm
Vita Health Products
150 Beghin Ave
Winnipeg
R2J 3W2
Manitoba
CANADA
Marketing Authorization Holder
Vita Health Products
150 Beghin Ave
Winnipeg
R2J 3W2
Manitoba
CANADA

B. Selection Extra Strength Flu Relief Daytime

DIN, NPN, DIN-HIM
DIN 02248580
Dosage form
  • Caplet
Strength
  • Dextromethorphan Hydrobromide, 15 mg
  • Pseudoephedrine Hydrochloride, 30 mg
  • Acetaminophen, 500 mg
Lot or serial number
  • 1I1152G5J
  • 0I12727QR
Companies
Recalling Firm
Vita Health Products
150 Beghin Ave
Winnipeg
R2J 3W2
Manitoba
CANADA
Marketing Authorization Holder
Vita Health Products
150 Beghin Ave
Winnipeg
R2J 3W2
Manitoba
CANADA

C. Option+ Extra Strength Flu Relief Daytime

DIN, NPN, DIN-HIM
DIN 02248580
Dosage form
  • Caplet
Strength
  • Dextromethorphan Hydrobromide, 15 mg
  • Pseudoephedrine Hydrochloride, 30 mg
  • Acetaminophen, 500 mg
Lot or serial number
  • 2C1332N8C
  • 1I1152G46
  • 0I1272A9C
Companies
Recalling Firm
Vita Health Products
150 Beghin Ave
Winnipeg
R2J 3W2
Manitoba
CANADA
Marketing Authorization Holder
Vita Health Products
150 Beghin Ave
Winnipeg
R2J 3W2
Manitoba
CANADA

Date modified: