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Apotex Product Recall (2015-04-10)
- Starting date:
- April 10, 2015
- Posting date:
- April 11, 2015
- Type of communication:
- Drug Recall
- Subcategory:
- Drugs
- Hazard classification:
- Type II and III
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-52887
Recalled Products
A. APO-Candesartan 16 mg (Type-II)
B. APO-Pregabalin 50 mg (Type-II)
C. APO-Pregabalin 75 mg (Type-II)
D. APO-Verap SR 240 mg (Type-III)
Reason
Out of specification results during stability testing for CAD-II impurity (APO-Candesartan), unidentified impurity (APO-Pregabalin) and dissolution test (APO-Verap SR)
Depth of distribution
Wholesaler and Distributor
Affected products
A. APO-Candesartan 16 mg (Type-II)
DIN, NPN, DIN-HIM
DIN 02365367
Dosage form
Tablets
Strength
Candesartan cilexetil 16 mg
Lot or serial number
KV5559, KV5562, KW0448, KV5560, KV5561
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-Pregabalin 50 mg (Type-II)
DIN, NPN, DIN-HIM
DIN 02394243
Dosage form
Capsules
Strength
Pregabaline 50 mg
Lot or serial number
KW3889
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-Pregabalin 75 mg (Type-II)
DIN, NPN, DIN-HIM
DIN 02394251
Dosage form
Capsules
Strength
Pregabaline 75 mg
Lot or serial number
KN9046
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-Verap SR 240 mg (Type-III)
DIN, NPN, DIN-HIM
DIN 02246895
Dosage form
Tablet (Extended-Release)
Strength
Verapamil hydrochloride 240 mg
Lot or serial number
KL7884
KL7885
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
Related AWRs
