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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

APO-Candesartan 16 mg (2015-05-01)

2015-05-01 | Health products

Recall

APO-Verap SR (2015-05-19)

2015-05-19 | Health products

Recall
Recall