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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