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Health product recall

Eprex Product Recall (2015-05-19)

Starting date:
May 19, 2015
Posting date:
May 21, 2015
Type of communication:
Drug Recall
Subcategory:
Drugs, Biologic/vaccine
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-53483

Recalled Products

A. Eprex Sterile Solution 1000 IU / 0.5 mL
B. Eprex Sterile Solution 2000 IU / 0.5 mL
C. Eprex Sterile Solution 3000 IU / 0.3 mL
D. Eprex Sterile Solution 4000 IU / 0.4 mL
E. Eprex Sterile Solution 6000 IU / 0.6 mL
F. Eprex Sterile Solution 8000 IU / 0.8 mL
G. Eprex Sterile Solution 10000 IU / 1.0 mL

Reason

Oxidized methionine level may not remain within registered specification throughout shelf-life.

Depth of distribution

Wholesalers and retailers

Affected products

A. Eprex Sterile Solution 1000 IU / 0.5 mL

DIN, NPN, DIN-HIM
DIN 02231583
Dosage form

Solution

Strength

Epoetin Alfa 1000 Unit / 0.5 mL

Lot or serial number

ECS1Q00
ECS1Q01

Companies
Recalling Firm
Janssen Inc.
19 Greenbelt Drive
Toronto
M3C 1L9
Ontario
CANADA
Marketing Authorization Holder
Janssen Inc.
19 Greenbelt Drive
Toronto
M3C 1L9
Ontario
CANADA

B. Eprex Sterile Solution 2000 IU / 0.5 mL

DIN, NPN, DIN-HIM
DIN 02231584
Dosage form

Solution

Strength

Epoetin Alfa 2000 Unit / 0.5 mL

Lot or serial number

EBS3P00
EES4I00
EHS4W00

Companies
Recalling Firm
Janssen Inc.
19 Greenbelt Drive
Toronto
M3C 1L9
Ontario
CANADA
Marketing Authorization Holder
Janssen Inc.
19 Greenbelt Drive
Toronto
M3C 1L9
Ontario
CANADA

C. Eprex Sterile Solution 3000 IU / 0.3 mL

DIN, NPN, DIN-HIM
DIN 02231585
Dosage form

Solution

Strength

Epoetin Alfa 3000 Unit / 0.3 mL

Lot or serial number

ECS2700

Companies
Recalling Firm
Janssen Inc.
19 Greenbelt Drive
Toronto
M3C 1L9
Ontario
CANADA
Marketing Authorization Holder
Janssen Inc.
19 Greenbelt Drive
Toronto
M3C 1L9
Ontario
CANADA

D. Eprex Sterile Solution 4000 IU / 0.4 mL

DIN, NPN, DIN-HIM
DIN 02231586
Dosage form

Solution

Strength

Epoetin Alfa 4000 Unit / 0.4 mL

Lot or serial number

EDS5X00
EAS2X00
EAS4300
EBS2T00
EBS5C00

Companies
Recalling Firm
Janssen Inc.
19 Greenbelt Drive
Toronto
M3C 1L9
Ontario
CANADA
Marketing Authorization Holder
Janssen Inc.
19 Greenbelt Drive
Toronto
M3C 1L9
Ontario
CANADA

E. Eprex Sterile Solution 6000 IU / 0.6 mL

DIN, NPN, DIN-HIM
DIN 02243401
Dosage form

Solution

Strength

Epoetin Alfa 6000 Unit / 0.6 mL

Lot or serial number

EAS4200
EJS4R00

Companies
Recalling Firm
Janssen Inc.
19 Greenbelt Drive
Toronto
M3C 1L9
Ontario
CANADA
Marketing Authorization Holder
Janssen Inc.
19 Greenbelt Drive
Toronto
M3C 1L9
Ontario
CANADA

F. Eprex Sterile Solution 8000 IU / 0.8 mL

DIN, NPN, DIN-HIM
DIN 02243403
Dosage form

Solution

Strength

Epoetin Alfa 8000 Unit / 0.8 mL

Lot or serial number

ECS3600
EGS6N00
EGS6N01
EHS4U00

Companies
Recalling Firm
Janssen Inc.
19 Greenbelt Drive
Toronto
M3C 1L9
Ontario
CANADA
Marketing Authorization Holder
Janssen Inc.
19 Greenbelt Drive
Toronto
M3C 1L9
Ontario
CANADA

G. Eprex Sterile Solution 10000 IU / 1.0 mL

DIN, NPN, DIN-HIM
DIN 02231587
Dosage form

Solution

Strength

Epoetin Alfa 10000 Unit / mL

Lot or serial number

EKS5N00

Companies
Recalling Firm
Janssen Inc.
19 Greenbelt Drive
Toronto
M3C 1L9
Ontario
CANADA
Marketing Authorization Holder
Janssen Inc.
19 Greenbelt Drive
Toronto
M3C 1L9
Ontario
CANADA

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