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Health product recall

Soframycin (2016-01-29)

Starting date:
January 29, 2016
Posting date:
March 4, 2016
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-57078

Affected Products

Soframycin

Reason

Out of specification result for potency during shelf life testing

Depth of distribution

Canadian wholesalers

Affected products

Soframycin

DIN, NPN, DIN-HIM
DIN 02224860
Dosage form

Nasal spray

Strength
  • Framycetin 12.5 mg/mL,
  • Gramicidin 0.05 mg/mL,
  • Phenylephrine HCL 2.5 mg/mL
Lot or serial number

F0622

Companies
Recalling Firm
ERFA Canada 2012 Inc.
8250 Decarie, Suite 110
Montreal
H4P 2P5
Quebec
CANADA
Marketing Authorization Holder
ERFA Canada 2012 Inc.
8250 Decarie, Suite 110
Montreal
H4P 2P5
Quebec
CANADA

Date modified: