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