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Health product recall

Novartis Pharmaceuticals Canada Product Recall (2015-04-16)

Starting date:
April 16, 2015
Posting date:
May 12, 2015
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-53337

Recalled Products

A. Sandostatin 50 mcg / mL

B. Sandostatin 100 mcg / mL

C. Sandostatin 200 mcg / mL

D. Sandostatin 500 mcg / mL

E. Sandostatin LAR 10 mg

F. Sandostatin LAR 20 mg

G. Sandostatin LAR 30 mg

H. Tobi

I. Xolair

J. Estalis 140 / 50 mcg

K. Estalis 250 / 50 mcg

L. Lucentis

Reason

Products were stored outside of recommended temperatures.

Depth of distribution

Shoppers Drug Mart Pharmacies in Ontario and Quebec

Affected products

A. Sandostatin 50 mcg / mL

DIN, NPN, DIN-HIM

DIN 00839191

Dosage form

Solution

Strength

Octreotide (Octreotide acetate) 50 µg / mL

Lot or serial number

S0056

Companies
Recalling Firm

Shoppers Drug Mart

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA

Marketing Authorization Holder

Novartis Pharmaceuticals Canada Inc.

385 Bouchard Boulevard

Dorval

H9S 1A9

Quebec

CANADA



B. Sandostatin 100 mcg / mL

DIN, NPN, DIN-HIM

DIN 00839205

Dosage form

Solution

Strength

Octreotide (Octreotide acetate) 100 µg / mL

Lot or serial number

S0243

Companies
Recalling Firm

Shoppers Drug Mart

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA

Marketing Authorization Holder

Novartis Pharmaceuticals Canada Inc.

385 Bouchard Boulevard

Dorval

H9S 1A9

Quebec

CANADA



C. Sandostatin 200 mcg / mL

DIN, NPN, DIN-HIM

DIN 02049392

Dosage form

Solution

Strength

Octreotide (Octreotide acetate) 200 µg / mL

Lot or serial number

S0078

Companies
Recalling Firm

Shoppers Drug Mart

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA

Marketing Authorization Holder

Novartis Pharmaceuticals Canada Inc.

385 Bouchard Boulevard

Dorval

H9S 1A9

Quebec

CANADA



D. Sandostatin 500 mcg / mL

DIN, NPN, DIN-HIM

DIN 00839213

Dosage form

Solution

Strength

Octreotide (Octreotide acetate) 500 µg / mL

Lot or serial number

S0024C

Companies
Recalling Firm

Shoppers Drug Mart

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA

Marketing Authorization Holder

Novartis Pharmaceuticals Canada Inc.

385 Bouchard Boulevard

Dorval

H9S 1A9

Quebec

CANADA



E. Sandostatin LAR 10 mg

DIN, NPN, DIN-HIM

DIN 02239323

Dosage form

Powder

Strength

Octreotide (Octreotide acetate) 10 mg / vial

Lot or serial number

S0009

Companies
Recalling Firm

Shoppers Drug Mart

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA

Marketing Authorization Holder

Novartis Pharmaceuticals Canada Inc.

385 Bouchard Boulevard

Dorval

H9S 1A9

Quebec

CANADA



F. Sandostatin LAR 20 mg

DIN, NPN, DIN-HIM

DIN 02239324

Dosage form

Powder

Strength

Octreotide (Octreotide acetate) 20 mg / vial

Lot or serial number

S0224

Companies
Recalling Firm

Shoppers Drug Mart

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA

Marketing Authorization Holder

Novartis Pharmaceuticals Canada Inc.

385 Bouchard Boulevard

Dorval

H9S 1A9

Quebec

CANADA



G. Sandostatin LAR 30 mg

DIN, NPN, DIN-HIM

DIN 02239325

Dosage form

Powder

Strength

Octreotide (Octreotide acetate) 30 mg / vial

Lot or serial number

S0053

Companies
Recalling Firm

Shoppers Drug Mart

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA

Marketing Authorization Holder

Novartis Pharmaceuticals Canada Inc.

385 Bouchard Boulevard

Dorval

H9S 1A9

Quebec

CANADA



H. Tobi

DIN, NPN, DIN-HIM

DIN 02239630

Dosage form

Solution

Strength

Tobramycin (Tobramycin sulfate) 300 mg / 5 mL

Lot or serial number

X5005

Companies
Recalling Firm

Shoppers Drug Mart

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA

Marketing Authorization Holder

Novartis Pharmaceuticals Canada Inc.

385 Bouchard Boulevard

Dorval

H9S 1A9

Quebec

CANADA



I. Xolair

DIN, NPN, DIN-HIM

DIN 02260565

Dosage form

Powder for solution

Strength

Omalizumab 150 mg / vial

Lot or serial number

S0041

S0038

Companies
Recalling Firm

Shoppers Drug Mart

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA

Marketing Authorization Holder

Novartis Pharmaceuticals Canada Inc.

385 Bouchard Boulevard

Dorval

H9S 1A9

Quebec

CANADA



J. Establis 140 / 50 mcg

DIN, NPN, DIN-HIM

DIN 02241835

Dosage form

Patch

Strength

Estradiol 0.62 mg

Norethindrone acetate 2.7 mg

Lot or serial number

76742

Companies
Recalling Firm

Shoppers Drug Mart

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA

Marketing Authorization Holder

Novartis Pharmaceuticals Canada Inc.

385 Bouchard Boulevard

Dorval

H9S 1A9

Quebec

CANADA



K. Estalis 250 / 50 mcg

DIN, NPN, DIN-HIM

DIN 02241837

Dosage form

Patch

Strength

Estradiol 0.51 mg

Norethindrone acetate 4.8 mg

Lot or serial number

76743

74572

Companies
Recalling Firm

Shoppers Drug Mart

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA

Marketing Authorization Holder

Novartis Pharmaceuticals Canada Inc.

385 Bouchard Boulevard

Dorval

H9S 1A9

Quebec

CANADA



L. Lucentis

DIN, NPN, DIN-HIM

DIN 02296810

Dosage form

Solution

Strength

Ranibizumab 10 mg / mL

Lot or serial number

S0074A

S0076A

Companies
Recalling Firm

Shoppers Drug Mart

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA

Marketing Authorization Holder

Novartis Pharmaceuticals Canada Inc.

385 Bouchard Boulevard

Dorval

H9S 1A9

Quebec

CANADA


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