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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
- 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