Health product recall

Naturalyte H-320 (2020-02-10)

Starting date:
February 10, 2020
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-72363

Last updated: 2020-02-18

Summary

  • Product:
    Naturalyte H-320 Solution

Reason

The sodium is out of specification in the affected lot.

Depth of distribution

End users

Affected products

Naturalyte H-320 Solution

DIN, NPN, DIN-HIM

DIN 02330229

Dosage form

Solution

Strength

  • Acetic acid 8.1 g/L
  • Calcium chloride 8.27 g/L
  • Dextrose 49.49 g/L
  • Magnesium chloride 4.57 g/L
  • Potassium chloride 6.71 g/L
  • Sodium chloride 289.3 g/L

Lot or serial number

18SMAC017

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 Renal Therapies Group, LLC

920 Winter Street

Waltham

02451

Massachusetts

UNITED STATES