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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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