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Acetaminophen 325 mg with 15 mg Caffeine and 8 mg Codeine Phosphate (2013-09-30)

Starting date:
September 30, 2013
Posting date:
October 21, 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-36323

Recalled Products

A. Encounter Acetaminophen 325 mg with 15 mg Caffeine and 8 mg Codeine Phosphate
B. Health One Acetaminophen 325 mg with 15 mg Caffeine and 8 mg Codeine Phosphate
C. Equate Acetaminophen 325 mg with 15 mg Caffeine and 8 mg Codeine Phosphate
D. Uniprix Acetaminophen 325 mg with 15 mg Caffeine and 8 mg Codeine Phosphate

Reason

The content uniformity of the codeine in the tablets is in question.  The codeine level may be present at a level as low as 80.1% of the label claim of 8 mg per tablet.

Depth of distribution

Distributed to the retail level.  Nationally in Canada only.

Affected products

A. Encounter Acetaminophen 325 mg with 15 mg Caffeine and 8 mg Codeine Phosphate
 

DIN, NPN, DIN-HIM
DIN 00706221
Dosage form

Tablet

Strength
  • Acetaminophen 325 mg
  • Caffeine 15 mg
  • Codeine 8 mg
Lot or serial number
  • 2J2852WLJ, 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

B. Health One Acetaminophen 325 mg with 15 mg Caffeine and 8 mg Codeine Phosphate
 

DIN, NPN, DIN-HIM
DIN 00706221
Dosage form

Tablet

Strength
  • Acetaminophen 325 mg
  • Caffeine 15 mg
  • Codeine 8 mg
Lot or serial number

2J2852XFC, 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. Equate Acetaminophen 325 mg with 15 mg Caffeine and 8 mg Codeine Phosphate
 

DIN, NPN, DIN-HIM
DIN 00706221
Dosage form

Tablet

Strength
  • Acetaminophen 325 mg
  • Caffeine 15 mg
  • Codeine 8 mg
Lot or serial number
  • 2J2852X2N, 200 count
  • 2J28530E2, 100 count
  • 2J2852XFF, 100 count
  • 2J2852W34, 50 count
  • 2J2852XFG, 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

D. Uniprix Acetaminophen 325 mg with 15 mg Caffeine and 8 mg Codeine Phosphate

DIN, NPN, DIN-HIM
DIN 00706221
Dosage form

Tablet

Strength
  • Acetaminophen 325 mg
  • Caffeine 15 mg
  • Codeine 8 mg
Lot or serial number
  • 2J2852YAG, 200 count
  • 2J2852ZLN, 200 count
  • 2J2852XFE, 100 count
  • 2J2852YTA, 30 count
  • 2J2852YAF, 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