Two Lots of Ratio-Prednisolone Eye Drops Recalled Due to Potential Health Risks

Starting date:

March 23, 2010

Posting date:

March 23, 2010

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Product Safety, Quality

Audience:

General Public

Identification number:

RA-110004164

• 
  Media enquiries
• 
  Public enquiries

Health Canada is advising consumers that Ratiopharm Inc., of Mirabel, Quebec, has voluntarily recalled all units from Lot HF26 and Lot HF27 of the prescription drug Ratio-Prednisolone Ophthalmic Solution (DIN 00700401) in 1.0% strength because some bottles may contain particles that could lead to increased eye irritation. Health Canada will continue to monitor the effectiveness of this recall.

Ratio-Prednisolone (1.0%) eye drops are taken for inflammation of the eye. Patients using the affected lots may notice visible particles in the bottle and may have difficulty squeezing out the product due to a blockage by particles. Potential adverse events may include a gritty feeling in the eye or general eye irritation and could lead to corneal abrasion. To date, only one adverse reaction of blurry vision has been reported in Canada that is associated with the use of this product.

This product should not be refrigerated or exposed to significant changes in temperature. Doing so may lead to clumping in the eye drop solution that could result in visible particles. Patients using this product from the two affected lots should consult their pharmacist to obtain a new lot and ensure that treatment of the original condition is not interrupted.

Ratiopharm Inc. has informed Health Canada that the manufacturer of the product, Allergan Inc., of Waco, Texas, has established that the affected lots were not temperature controlled when shipped to Canada. As such, Ratiopharm Inc. has informed Health Canada that the manufacturer has introduced measures to ensure the appropriate temperature control during transportation of the eye drops.

Drugs and natural health products that are authorized for sale in Canada will have either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality.

Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at 613-957-2991, or toll free at

1-866-225-0709.

You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

• Report online at the MedEffect™ Canada section of the Health Canada website
• Call toll-free at 1-866-234-2345
• Complete a Canada Vigilance Reporting Form and either:
  • Fax toll-free to 1-866-678-6789
  • Mail to: Canada Vigilance Program
    
    Health Canada
    
    AL 0701D
    
    Ottawa, ON K1A 0K9

To have postage pre-paid, download the postage paid label from the MedEffect™ Canada section of the Health Canada website. The Canada Vigilance Reporting Form and the adverse reaction reporting guidelines may also be obtained via this section.

 

Media enquiries

Health Canada

613-957-2983

Public enquiries

613-957-2991

1-866-225-0709