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Health product recall

Acetaminophen 300 mg with Caffeine 15 mg and 8 mg Codeine Phosphate (2013-09-30)

Starting date:
September 30, 2013
Posting date:
November 6, 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-36325

Recalled Products

A. Pharmasave Acetaminophen 300 mg with Caffeine 15 mg and 8 mg Codeine Phosphate
B. Equate Acetaminophen 300 mg with Caffeine 15 mg and 8 mg Codeine Phosphate
C. Encounter Acetaminophen 300 mg with Caffeine 15 mg and 8 mg Codeine Phosphate
D. Stanley Acetaminophen 300 mg with Caffeine 15 mg and 8 mg Codeine Phosphate
E. Exact Acetaminophen 300 mg with Caffeine 15 mg and 8 mg Codeine Phosphate
F. Overwaitea Acetaminophen 300 mg with Caffeine 15 mg and 8 mg Codeine Phosphate
G. Compliments Acetaminophen 300 mg with Caffeine 15 mg and 8 mg Codeine Phosphate

Reason

The codeine content in the tablets may be present at a level as low as 71.6% or as high as 118.8% of the label claim of 8 mg per tablet.

Depth of distribution

Distributed to the retail level. Nationally in Canada only.

Affected products

A. Pharmasave Acetaminophen 300 mg with Caffeine 15 mg and 8 mg Codeine Phosphate
 

DIN, NPN, DIN-HIM
DIN 02154234
Dosage form

Tablet

Strength
  • Acetaminophen 300 mg
  • Caffeine 15 mg
  • Codeine 8 mg
Lot or serial number
  • 2J0902V50, 200 Count
  • 2L1672XLP, 200 Count
  • 2L1672YKH, 30 Count
  • 2L1672YKG, 50 Count
Companies
Recalling Firm
Vita Health Products Inc.
150 Beghin Ave.
Winnipeg
R2J 3W2
Manitoba
CANADA
Marketing Authorization Holder
Vita Health Products Inc.
150 Beghin Ave.
Winnipeg
R2J 3W2
Manitoba
CANADA

B. Equate Acetaminophen 300 mg with Caffeine 15 mg and 8 mg Codeine Phosphate
 

DIN, NPN, DIN-HIM
DIN 02154234
Dosage form

Tablet

Strength
  • Acetaminophen 300 mg
  • Caffeine 15 mg
  • Codeine 8 mg
Lot or serial number
  • 2J0452THC, 50 count
  • 2J0452UKF, 100 count
  • 2I2342UJ3, 200 count
  • 2D0482PNN, 200 count
  • 2J1262UJ2, 200 count
  • 2J0072UKF, 100 count
  • 2J0072UJ3, 200 count
Companies
Recalling Firm
Vita Health Products Inc.
150 Beghin Ave.
Winnipeg
R2J 3W2
Manitoba
CANADA
Marketing Authorization Holder
Vita Health Products Inc.
150 Beghin Ave.
Winnipeg
R2J 3W2
Manitoba
CANADA

C. Encounter Acetaminophen 300 mg with Caffeine 15 mg and 8 mg Codeine Phosphate
 

DIN, NPN, DIN-HIM
DIN 02154234
Dosage form

Tablet

Strength
  • Acetaminophen 300 mg
  • Caffeine 15 mg
  • Codeine 8 mg
Lot or serial number
  • 2J0452U38, 100 count
Companies
Recalling Firm
Vita Health Products Inc.
150 Beghin Ave.
Winnipeg
R2J 3W2
Manitoba
CANADA
Marketing Authorization Holder
Vita Health Products Inc.
150 Beghin Ave.
Winnipeg
R2J 3W2
Manitoba
CANADA

D. Stanley Acetaminophen 300 mg with Caffeine 15 mg and 8 mg Codeine Phosphate
 

DIN, NPN, DIN-HIM
DIN 02154234
Dosage form

Tablet

Strength
  • Acetaminophen 300 mg
  • Caffeine 15 mg
  • Codeine 8 mg
Lot or serial number
  • 2I2342UWZ, 200 Count
  • 2D04292PY5, 200 Count
Companies
Recalling Firm
Vita Health Products Inc.
150 Beghin Ave.
Winnipeg
R2J 3W2
Manitoba
CANADA
Marketing Authorization Holder
Vita Health Products Inc.
150 Beghin Ave.
Winnipeg
R2J 3W2
Manitoba
CANADA

E. Exact Acetaminophen 300 mg with Caffeine 15 mg and 8 mg Codeine Phosphate
 

DIN, NPN, DIN-HIM
DIN 02154234
Dosage form

Tablet

Strength
  • Acetaminophen 300 mg
  • Caffeine 15 mg
  • Codeine 8 mg
Lot or serial number
  • 2L1672YQB, 50 count
  • 2D0482PAA, 100 count
  • 2D0482PKS, 200 count
  • 2D0492PKS, 200 count
  • 2H0482T5B, 200 count
Companies
Recalling Firm
Vita Health Products Inc.
150 Beghin Ave.
Winnipeg
R2J 3W2
Manitoba
CANADA
Marketing Authorization Holder
Vita Health Products Inc.
150 Beghin Ave.
Winnipeg
R2J 3W2
Manitoba
CANADA

F. Overwaitea Acetaminophen 300 mg with Caffeine 15 mg and 8 mg Codeine Phosphate
 

DIN, NPN, DIN-HIM
DIN 02154234
Dosage form

Tablet

Strength
  • Acetaminophen 300 mg
  • Caffeine 15 mg
  • Codeine 8 mg
Lot or serial number
  • 2D0482PNP, 100 count
  • 2J0072U29, 100 count
Companies
Recalling Firm
Vita Health Products Inc.
150 Beghin Ave.
Winnipeg
R2J 3W2
Manitoba
CANADA
Marketing Authorization Holder
Vita Health Products Inc.
150 Beghin Ave.
Winnipeg
R2J 3W2
Manitoba
CANADA

G. Compliments Acetaminophen 300 mg with Caffeine 15 mg and 8 mg Codeine Phosphate

DIN, NPN, DIN-HIM
DIN 02154234
Dosage form

Tablet

Strength
  • Acetaminophen 300 mg
  • Caffeine 15 mg
  • Codeine 8 mg
Lot or serial number
  • 2D0492PY4, 30 count
Companies
Recalling Firm
Vita Health Products Inc.
150 Beghin Ave.
Winnipeg
R2J 3W2
Manitoba
CANADA
Marketing Authorization Holder
Vita Health Products Inc.
150 Beghin Ave.
Winnipeg
R2J 3W2
Manitoba
CANADA

Date modified: