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