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Health product recall

A.C.& C 8 mg Tab (2014-12-01)

Starting date:
December 1, 2014
Posting date:
December 12, 2014
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-42915

Recalled Products

  1. London Drugs A.C.& C 8 mg Tab
  2. Stanley A.C.& C 8 mg Tab
  3. Equate A.C.& C 8 mg Tab
  4. Life Brand A.C.& C 8 mg Tab

Reason

A sample of the product failed to meet the codeine phosphate assay requirement of 90.0-110.0% at the 24 month stability time point; expiry date of the product is 36 months. The result obtained from the investigation was 87.8%.

Depth of distribution

Wholesaler

Affected products

London Drugs A.C.& C 8 mg Tab, Stanley A.C.& C 8 mg Tab, Equate A.C.& C 8 mg Tab, Life Brand A.C.& C 8 mg Tab

DIN, NPN, DIN-HIM
DIN 00180041
Dosage form

Tablet

Strength
  • Acetylsalicylic Acid 375 mg
  • Caffeine 15 mg
  • Codeine Phosphate 8 mg
Lot or serial number
  • 2H1502X6S
  • 3F250370J
  • 3F250341Y
  • 3F250343T
  • 2G0022S2F
  • 4E2563BF4
  • 4E2563BNL
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