Health product recall

Ferric Subsulfate Solution (2019-07-22)

Starting date:
July 22, 2019
Type of communication:
Drug Recall
Subcategory:
Natural health products
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-70633

Last updated: 2019-08-07

Summary

  • Product:
    Ferric Subsulfate Solution

Reason

Affected lot contains iron levels outside of the labelled claim and may contain the presence of microbiological contamination. Regulated party does not hold a Site Licence for sale of the product in Canada and the product was sold without market authorization (NPN) in Canada.

Depth of distribution

Healthcare Establishments

Affected products

Ferric Subsulfate Solution

DIN, NPN, DIN-HIM

No market authorization

Dosage form

Solution

Strength

0.20 - 0.22 g of Fe per 1 ml

Lot or serial number

579635

Companies

Recalling Firm

Superior Medical Limited

520 Champagne Drive,

Toronto

M3J 2C6

Ontario

CANADA

Marketing Authorization Holder

N/A