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Health product recall

Clinimix Recall (2014-05-29)

Starting date:
May 29, 2014
Posting date:
June 24, 2014
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-39913

Recalled Products

A. Clinimix E

B. Clinimix

C. Clinimix E

D. Clinimix

Reason

Recall expanded to four additional lots as a precautionay measure due to the detection of particulate matter.

Depth of distribution

Hospitals in Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Nova Scotia, Ontario, Quebec, Saskatchewan, Prince Edward Island

Affected products

A. Clinimix E

DIN, NPN, DIN-HIM
DIN 02014076
Dosage form

Intravenous Solution

Strength

Dextrose - 10 g/100 mL
Glycine - 1.04 g/100 mL
Histidine - 220 mg/100 mL
L-Alanine - 1.04 g/100 mL
L-Arginine - 520 mg/100 mL
L-Isoleucine - 240 mg/100 mL
L-Leucine Hydrochloride - 310 mg/100 mL
L-Lysine Hydrochloride - 290 mg/100 mL
L-Methionine - 290 mg/100 mL
L-Phenylalanine Hydrochloride - 310 mg/100 mL
L-Proline - 210 mg/100 mL
L-Threonine - 210 mg/100 mL
L-Tyrosine - 20 mg/100 mL
L-Valine - 230 mg/100 mL
Magnesium Chloride - 51 mg/100 mL
Potassium Phosphate Dibasic-261 mg/100 mL
Sodium Acetate-340 mg/100 mL
Sodium Chloride-58.5 mg/100 mL
Tryptophan - 90 mg/100 mL

Lot or serial number

W3L11C2

Companies
Recalling Firm
Baxter Corporation
7125 Mississauga Rd.
Mississauga
L5N 0C2
Ontario
CANADA
Marketing Authorization Holder
Baxter Corporation
7125 Mississauga Rd.
Mississauga
L5N 0C2
Ontario
CANADA

B. Clinimix

DIN, NPN, DIN-HIM
DIN 02046709
Dosage form

Intravenous Solution

Strength

Dextrose - 16.6 g/100 mL
Glycine - 1040 mg/100 mL
Histidine - 220 mg/100 mL
L-Alanine - 1040 mg/100 mL
L-Arginine - 520 mg/100 mL
L-Isoleucine - 240 mg/100 mL
L-Leucine Hydrochloride - 310 mg/100 mL
L-Lysine Hydrochloride - 290 mg/100 mL
L-Methionine - 290 mg/100 mL
L-Phenylalanine Hydrochloride - 310 mg/100 mL
L-Proline - 210 mg/100 mL
L-Threonine - 210 mg/100 mL
L-Tyrosine - 20 mg/100 mL
L-Valine - 230 mg/100 mL
Tryptophan - 90 mg/100 mL

Lot or serial number

W3K13C2

Companies
Recalling Firm
Baxter Corporation
7125 Mississauga Rd.
Mississauga
L5N 0C2
Ontario
CANADA
Marketing Authorization Holder
Baxter Corporation
7125 Mississauga Rd.
Mississauga
L5N 0C2
Ontario
CANADA

C. Clinimix E

DIN, NPN, DIN-HIM
DIN 02014068
Dosage form

Intravenous Solution

Strength

Dextrose - 20 g/100 mL
Glycine - 1.04 g/100 mL
Histidine - 220 mg/100 mL
L-Alanine - 1.04 g/100 mL
L-Arginine - 520 mg/100 mL
L-Isoleucine - 240 mg/100 mL
L-Leucine Hydrochloride - 310 mg/100 mL
L-Lysine Hydrochloride - 290 mg/100 mL
L-Methionine - 290 mg/100 mL
L-Phenylalanine Hydrochloride - 310 mg/100 mL
L-Proline - 210 mg/100 mL
L-Threonine - 210 mg/100 mL
L-Tyrosine - 20 mg/100 mL
L-Valine - 230 mg/100 mL
Magnesium Chloride - 51 mg/100 mL
Potassium Phosphate Dibasic-261 mg/100 mL
Sodium Acetate-340 mg/100 mL
Sodium Chloride-58.5 mg/100 mL
Tryptophan - 90 mg/100 mL

Lot or serial number

W3J23C3

Companies
Recalling Firm
Baxter Corporation
7125 Mississauga Rd.
Mississauga
L5N 0C2
Ontario
CANADA
Marketing Authorization Holder
Baxter Corporation
7125 Mississauga Rd.
Mississauga
L5N 0C2
Ontario
CANADA

D. Clinimix

DIN, NPN, DIN-HIM
DIN 02013959
Dosage form

Intravenous Solution

Strength

Dextrose - 20 g/100 mL
Glycine - 1.04 g/100 mL
Histidine - 220 mg/100 mL
L-Alanine - 1.04 g/100 mL
L-Arginine - 520 mg/100 mL
L-Isoleucine - 240 mg/100 mL
L-Leucine Hydrochloride - 310 mg/100 mL
L-Lysine Hydrochloride - 290 mg/100 mL
L-Methionine - 290 mg/100 mL
L-Phenylalanine Hydrochloride - 310 mg/100 mL
L-Proline - 210 mg/100 mL
L-Threonine - 210 mg/100 mL
L-Tyrosine - 20 mg/100 mL
L-Valine - 230 mg/100 mL
Magnesium Chloride - 51 mg/100 mL
Potassium Phosphate Dibasic-261 mg/100 mL
Sodium Acetate-340 mg/100 mL
Sodium Chloride-58.5 mg/100 mL
Tryptophan - 90 mg/100 mL

Lot or serial number

W3K11C3

Companies
Recalling Firm
Baxter Corporation
7125 Mississauga Rd.
Mississauga
L5N 0C2
Ontario
CANADA
Marketing Authorization Holder
Baxter Corporation
7125 Mississauga Rd.
Mississauga
L5N 0C2
Ontario
CANADA

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