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Apo-Diltiaz CD (2014-02-21)
- Starting date:
- March 3, 2014
- Posting date:
- March 10, 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-38177
Recalled products
- Apo-Diltiaz CD, 120 mg
- Apo-Diltiaz CD, 180 mg
- Apo-Diltiaz CD, 240 mg
- Apo-Diltiaz CD, 300 mg
Reason
Dissolution may not meet specification for 30 hours timepoint over shelf-life.
Depth of distribution
Wholesalers, Distributors in Alberta, British Columbia, Manitoba, Newfoundland and Labrador, Nova Scotia, Ontario, Quebec, Saskatchewan
Affected products
A. Apo-Diltiaz CD, 120 mg
DIN, NPN, DIN-HIM
DIN 02230997
Dosage form
Controlled Delivery Capsule
Strength
- 120 mg
Lot or serial number
- KM5030
Companies
- Recalling Firm
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
- Marketing Authorization Holder
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
B. Apo-Diltiaz CD, 180 mg
DIN, NPN, DIN-HIM
DIN 02230998
Dosage form
Controlled Delivery Capsule
Strength
- 180 mg
Lot or serial number
- KH1025
- KK9634
- KL5889
- KH1027
Companies
- Recalling Firm
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
- Marketing Authorization Holder
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
C. Apo-Diltiaz CD, 240 mg
DIN, NPN, DIN-HIM
DIN 02230999
Dosage form
Controlled Delivery Capsule
Strength
- 240 mg
Lot or serial number
- KH1026
Companies
- Recalling Firm
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
- Marketing Authorization Holder
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
D. Apo-Diltiaz CD, 300 mg
DIN, NPN, DIN-HIM
DIN 02229526
Dosage form
Controlled Delivery Capsule
Strength
- 300 mg
Lot or serial number
- KM5025
- KN2289
Companies
- Recalling Firm
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
- Marketing Authorization Holder
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA