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Health product recall

Muro 128 5% Ointment (2014-06-02)

Starting date:
June 2, 2014
Posting date:
June 18, 2014
Type of communication:
Drug Recall
Subcategory:
Natural health products
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-40021

Recalled Products

Muro 128 5% Ointment

Reason

Global Safety and Vigilance signal alert associated with an Adverse Drug Event with an observed increase in complaints associated with gritty, sand like feeling in the eye.

Sample analysis revealed crystal precipitates in the product.

Depth of distribution

Retailers, pharamcies, clinics in Ontario, Manitoba, Alberta, British Columbia, Quebec, Newfoundland, New Brunswick Saskatchewan and Nova Scotia

Affected products

Muro 128 5% Ointment

DIN, NPN, DIN-HIM

NPN 00750816

Dosage form

Ointment

Strength

Sodium Chloride - 5% (50.0 mg/g)

Lot or serial number

146931, 153621, 160911, 162421, 169272, 174881, 176931, 182771, 186721, 190181

Companies
Recalling Firm

Bausch & Lomb Canada Inc.

520 Applewood Crescent

Vaughan

L4K 4B4

Ontario

CANADA

Marketing Authorization Holder

Bausch & Lomb Inc.

8500 Hidden River Parkway

Tampa

33637

Florida

UNITED STATES