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Health product recall

Naturalyte Recall (2014-04-29)

Starting date:
April 29, 2014
Posting date:
June 17, 2014
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-40019

Recalled Products

A. Naturalyte H-631

B. Naturayte H-617

C. Naturalyte H-410

D. Naturalyte H-332

E. Naturalyte H-330

F. Naturalyte H-232

G. Naturalyte H-229

H. Naturalyte H-200

Reason

A manufacturing error was identified with caps supplied to Fresenius for use in finished product manufacturing. Particulate matter may be on the adhesive liner of the caps.

Depth of distribution

Hospitals, clinics and  home patient programs who may have received the affected lots.

Affected products

A. Naturalyte H-631

DIN, NPN, DIN-HIM
DIN 02327090
Dosage form

Solution

Strength

Acetic Acid - 10.81 g/L
Calcium Chloride - 6.62 g/L
Dextrose - 74.28 g/L
Magnesium Chloride - 4.57 g/L
Potassium Chloride - 6.71 g/L
Sodium Chloride - 263 g/L

Lot or serial number

14CMAC023

Companies
Recalling Firm
Fresenius Medical Care Canada Inc.
45 Staples Avenue, Suite 110
Richmond Hill
L4B 4W6
Ontario
CANADA
Marketing Authorization Holder
Fresenius Medical Care Canada Inc.
45 Staples Avenue, Suite 110
Richmond Hill
L4B 4W6
Ontario
CANADA

B. Naturayte H-617

DIN, NPN, DIN-HIM
DIN 02326922
Dosage form

Solution

Strength

Acetic Acid - 10.81 g/L
Calcium Chloride - 8.27 g/L
Dextrose - 98.99 g/L
Magnesium Chloride - 3.43 g/L
Potassium Chloride - 10.06 g/L
Sodium Chloride - 263 g/L

Lot or serial number

14CMAC037, 14CMAC056

Companies
Recalling Firm
Fresenius Medical Care Canada Inc.
45 Staples Avenue, Suite 110
Richmond Hill
L4B 4W6
Ontario
CANADA
Marketing Authorization Holder
Fresenius Medical Care Canada Inc.
45 Staples Avenue, Suite 110
Richmond Hill
L4B 4W6
Ontario
CANADA

C. Naturalyte H-410

DIN, NPN, DIN-HIM
DIN 02327511
Dosage form

Solution

Strength

Acetic Acid - 10.8 g/L
Calcium Chloride - 6.61 g/L
Dextrose - 49.49 g/L
Magnesium Chloride - 4.57 g/L
Potassium Chloride - 6.71 g/L
Sodium Chloride - 263 g/L

Lot or serial number

14CMAC026

Companies
Recalling Firm
Fresenius Medical Care Canada Inc.
45 Staples Avenue, Suite 110
Richmond Hill
L4B 4W6
Ontario
CANADA
Marketing Authorization Holder
Fresenius Medical Care Canada Inc.
45 Staples Avenue, Suite 110
Richmond Hill
L4B 4W6
Ontario
CANADA

D. Naturalyte H-332

DIN, NPN, DIN-HIM
DIN 02327333
Dosage form

Solution

Strength

Acetic Acid - 10.8 g/L
Calcium Chloride - 8.27 g/L
Dextrose - 49.49 g/L
Magnesium Chloride - 6.86 g/L
Potassium Chloride - 10.06 g/L
Sodium Chloride - 263 g/L

Lot or serial number

14CMAC038, 14CMAC057, 14CMAC068

Companies
Recalling Firm
Fresenius Medical Care Canada Inc.
45 Staples Avenue, Suite 110
Richmond Hill
L4B 4W6
Ontario
CANADA
Marketing Authorization Holder
Fresenius Medical Care Canada Inc.
45 Staples Avenue, Suite 110
Richmond Hill
L4B 4W6
Ontario
CANADA

E. Naturalyte H-330

DIN, NPN, DIN-HIM
DIN 02327503
Dosage form

Solution

Strength

Acetic Acid - 10.8 g/L
Calcium Chloride - 8.27 g/L
Dextrose - 49.49 g/L
Magnesium Chloride - 3.43 g/L
Potassium Chloride - 10.06 g/L
Sodium Chloride - 263 g/L

Lot or serial number

14CMAC048

Companies
Recalling Firm
Fresenius Medical Care Canada Inc.
45 Staples Avenue, Suite 110
Richmond Hill
L4B 4W6
Ontario
CANADA
Marketing Authorization Holder
Fresenius Medical Care Canada Inc.
45 Staples Avenue, Suite 110
Richmond Hill
L4B 4W6
Ontario
CANADA

F. Naturalyte H-232

DIN, NPN, DIN-HIM
DIN 02330253
Dosage form

Solution

Strength

Acetic Acid - 10.8 g/L
Calcium Chloride - 8.27 g/L
Dextrose - 49.49 g/L
Magnesium Chloride - 3.43 g/L
Potassium Chloride - 6.71 g/L
Sodium Chloride - 263 g/L

Lot or serial number

14CMAC039, 14CMAC041

Companies
Recalling Firm
Fresenius Medical Care Canada Inc.
45 Staples Avenue, Suite 110
Richmond Hill
L4B 4W6
Ontario
CANADA
Marketing Authorization Holder
Fresenius Medical Care Canada Inc.
45 Staples Avenue, Suite 110
Richmond Hill
L4B 4W6
Ontario
CANADA

G. Naturalyte H-229

DIN, NPN, DIN-HIM
DIN 02326949
Dosage form

Solution

Strength

Acetic Acid - 10.8 g/L
Calcium Chloride - 9.92 g/L
Dextrose - 49.49 g/L
Magnesium Chloride - 4.57 g/L
Potassium Chloride - 6.71 g/L
Sodium Chloride - 263 g/L

Lot or serial number

14CMAC042

Companies
Recalling Firm
Fresenius Medical Care Canada Inc.
45 Staples Avenue, Suite 110
Richmond Hill
L4B 4W6
Ontario
CANADA
Marketing Authorization Holder
Fresenius Medical Care Canada Inc.
45 Staples Avenue, Suite 110
Richmond Hill
L4B 4W6
Ontario
CANADA

H. Naturalyte H-200

DIN, NPN, DIN-HIM
DIN 02330172
Dosage form

Solution

Strength

Acetic Acid - 10.8 g/L
Calcium Chloride - 9.92 g/L
Dextrose - 98.99 g/L
Magnesium Chloride - 3.43 g/L
Potassium Chloride - 6.71 g/L
Sodium Chloride - 263 g/L

Lot or serial number

14CMAC040, 14CMAC024, 14CMAC025

Companies
Recalling Firm
Fresenius Medical Care Canada Inc.
45 Staples Avenue, Suite 110
Richmond Hill
L4B 4W6
Ontario
CANADA
Marketing Authorization Holder
Fresenius Medical Care Canada Inc.
45 Staples Avenue, Suite 110
Richmond Hill
L4B 4W6
Ontario
CANADA

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