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Health product recall

Hoffmann-La Roche 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-53333

Recalled Products

A. Actemra 80 mg / 4 mL

B. Actemra 200 mg / 10 mL

C. Actemra 400 mg / 20 mL

D. Avastin

E. Rituxan

F. Nutropin AQ Nuspin 10

G. Nutropin AQ Pen Cartridge

H. Pegasys

I. Pegasys RBV

J. Pulmozyme 1 mg / mL

Reason

Products were stored outside of recommended temperatures.

Depth of distribution

Shoppers Drug Mart Pharmacies in Ontario and Quebec

Affected products

A. Actemra 80 mg / 4 mL

DIN, NPN, DIN-HIM

DIN 02350092

Dosage form

Solution

Strength

Tocilizumab 80 mg / 4 mL

Lot or serial number

B2028B10

Companies
Recalling Firm

Shoppers Drug Mart

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA

Marketing Authorization Holder

Hoffmann - La Roche Ltd

7070 Mississauga Road

Mississauga

L5N 5M8

Ontario

CANADA



B. Actemra 200 mg / 10 mL

DIN, NPN, DIN-HIM

DIN 02350106

Dosage form

Solution

Strength

Tocilizumab 200 mg / 10 mL

Lot or serial number

B2032B103

B2038B05

B2040B15

Companies
Recalling Firm

Shoppers Drug Mart

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA

Marketing Authorization Holder

Hoffmann - La Roche Ltd

7070 Mississauga Road

Mississauga

L5N 5M8

Ontario

CANADA



C. Actemra 400 mg / 20 mL

DIN, NPN, DIN-HIM

DIN 02350114

Dosage form

Solution

Strength

Tocilizumab 400 mg / 20 mL

Lot or serial number

B2044B06

Companies
Recalling Firm

Shoppers Drug Mart

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA

Marketing Authorization Holder

Hoffmann - La Roche Ltd

7070 Mississauga Road

Mississauga

L5N 5M8

Ontario

CANADA



D. Avastin

DIN, NPN, DIN-HIM

DIN 02270994

Dosage form

Solution

Strength

Bevacizumab 25 mg / mL

Lot or serial number

N3667B01

N3699B02

Companies
Recalling Firm

Shoppers Drug Mart

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA

Marketing Authorization Holder

Hoffmann - La Roche Ltd

7070 Mississauga Road

Mississauga

L5N 5M8

Ontario

CANADA



E. Rituxan

DIN, NPN, DIN-HIM

DIN 02241927

Dosage form

Solution

Strength

Rituximab 10 mg / mL

Lot or serial number

H0795B01

Companies
Recalling Firm

Shoppers Drug Mart

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA

Marketing Authorization Holder

Hoffmann - La Roche Ltd

7070 Mississauga Road

Mississauga

L5N 5M8

Ontario

CANADA



F. Nutropin AQ Nuspin 10

DIN, NPN, DIN-HIM

DIN 02376393

Dosage form

Solution

Strength

Somatropin 10 mg / 2 mL

Lot or serial number

636139

Companies
Recalling Firm

Shoppers Drug Mart

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA

Marketing Authorization Holder

Hoffmann - La Roche Ltd

7070 Mississauga Road

Mississauga

L5N 5M8

Ontario

CANADA



G. Nutropin AQ Pen Cartridge

DIN, NPN, DIN-HIM

DIN 02249002

Dosage form

Solution

Strength

Somatropin 10 mg / 2 mL

Lot or serial number

597434

Companies
Recalling Firm

Shoppers Drug Mart

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA

Marketing Authorization Holder

Hoffmann - La Roche Ltd

7070 Mississauga Road

Mississauga

L5N 5M8

Ontario

CANADA



H. Pegasys

DIN, NPN, DIN-HIM

DIN 02248077

Dosage form

Solution

Strength

Peginterferon Alfa-2A 180 µG / 0.5 mL

Lot or serial number

B1352B15

B1036B013

Companies
Recalling Firm

Shoppers Drug Mart

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA

Marketing Authorization Holder

Hoffmann - La Roche Ltd

7070 Mississauga Road

Mississauga

L5N 5M8

Ontario

CANADA



I. Pegasys RBV

DIN, NPN, DIN-HIM

DIN 02253429

Dosage form

Solution, Tablet

Strength

Peginterferon Alfa-2A 180 µG / 0.5 mL

Ribavirin 200 mg / Tab

Lot or serial number

N0169B01/B1344B073

NO220B043/B1331B213

NO244B043/B1348B133

NO280B033/B1348B133

NO286B023/B1331B023

NO280B023/B1348B153

N0268B033/B0136B133

N0269B073/B1036B103

N0269B043/B1036B123

N0269B0253/B0136B073

Companies
Recalling Firm

Shoppers Drug Mart

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA

Marketing Authorization Holder

Hoffmann - La Roche Ltd

7070 Mississauga Road

Mississauga

L5N 5M8

Ontario

CANADA



J. Pulmozyme 1 mg / mL

DIN, NPN, DIN-HIM

DIN 02046733

Dosage form

Solution

Strength

Dornase alfa 1 mg / mL

Lot or serial number

N0094B03

Companies
Recalling Firm

Shoppers Drug Mart

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA

Marketing Authorization Holder

Hoffmann - La Roche Ltd

7070 Mississauga Road

Mississauga

L5N 5M8

Ontario

CANADA


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