Public recall detail

Soframycin nasal spray; Out of specification (pH & benzalkonium chloride)

2025-06-10

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Recall Safety notice
Quick summary

Quick summary: Soframycin nasal spray; Out of specification (pH & benzalkonium chloride). Date: 2025-06-10.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Soframycin nasal spray; Out of specification (pH & benzalkonium chloride). Date: 2025-06-10.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandSearchlight Pharma
ProductSoframycin nasal spray
IssueHealth products - Product quality
Recall classType III
IdentificationRA-77578

Affected products

BrandSearchlight Pharma
ProductSoframycin nasal spray
DIN / NPN / authorizationDIN 02224860
Dosage formSpray
StrengthFramycetin sulfate 12.5 mg/mL Gramicidin 0.05 mg/mL Phenylephrine hydrochloride 2.5 mg/mL
Lot24C24

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 official information
AudienceGeneral public Healthcare Industry
CategoryHealth products - Drugs
CompaniesSearchlight Pharma Inc. 1600 Rue Notre Dame Ouest, Suite 312 Montreal Quebec H3J 1M1 Canada
Published byHealth Canada
Recall classType III
Alert / recall typeHealth product recall
Identification numberRA-77578
Background{}
CompaniesSearchlight Pharma Inc. 1600 Rue Notre Dame Ouest, Suite 312 Montreal Quebec H3J 1M1 Canada
AudiencesGeneral public Healthcare Industry
Source updated2025-06-10

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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