Soframycin nasal spray; Out of specification (pH & benzalkonium chloride)
Brand(s)
Last updated
Summary
Product
Soframycin nasal spray
Issue
Health products - Product quality
What to do
Consult your health care professional if you have any health concerns.
Affected products
| Brand | Product Name | Market Authorization | Dosage Form | Strength | Lot number |
|---|---|---|---|---|---|
| Searchlight Pharma | Soframycin nasal spray | DIN 02224860 | Spray | Framycetin sulfate 12.5 mg/mL Gramicidin 0.05 mg/mL Phenylephrine hydrochloride 2.5 mg/mL | 24C24 |
Issue
The pH and benzalkonium chloride content are out of specification in the affected lot.
What you should do
- Verify if your product is affected.
- Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.
- Contact the recalling firm if you have any questions about the recall.
- Report any health product related side effects to Health Canada.
- Report any other health product safety complaints to Health Canada.
Additional information
Background
Depth of recall: Wholesalers
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Drugs
Companies
Searchlight Pharma Inc.
1600 Rue Notre Dame Ouest, Suite 312
Montreal Quebec H3J 1M1 Canada
Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type III
Identification number
RA-77578
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