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