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Health product recall

Diltiazem CD (2013-12-17)

Starting date:
December 17, 2013
Posting date:
January 13, 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-37485

Recalled products

  1. Diltiazem CD

Reason

6 month stability testing for dissolution failed specification of 75% at 30 hours. The actual result was 74v% at 30 hours.

Depth of distribution

Wholesalers and pharmacies across Canada

Affected products

A. Diltiazem CD

DIN, NPN, DIN-HIM
DIN 02400456
Dosage form

Capsules

Strength
  • 240 mg
Lot or serial number
  • KL2734
Companies
Recalling Firm
Sanis Health Inc.
102 - 333 Champlain Street
Dieppe
E1A 1P2
New Brunswick
CANADA
Marketing Authorization Holder
Sanis Health Inc.
102 - 333 Champlain Street
Dieppe
E1A 1P2
New Brunswick
CANADA

Date modified: