Expanded Voluntary Recall and Product Discontinuation of Murocel Methylcellulose Lubricant Ophthalmic Solution USP, 1% Sterile
FOR RELEASE MONDAY, AUGUST, 8, 2011
MADISON, NJ - Bausch + Lomb, the global eye health company, is conducting a voluntary recall of six lots of Murocel® Methylcellulose Lubricant Ophthalmic Solution, USP 1%, only available within the United States. (Expiry dates: 09-30-2011 through 01-31-2013). Following this voluntary product recall, Bausch + Lomb will discontinue the product entirely.
This voluntary recall and product discontinuation is limited only to the United States; it does not affect locations in Europe, the Middle East or Asia-Pacific regions.
Please Note: This event is an expansion of the voluntary recall of a single lot of Murocel® which was initiated on July 6, 2011. See media advisory here.
Bausch + Lomb has chosen to initiate this six-lot recall based on routine stability testing which showed the lots were out of specification for preservative efficacy. There have been no adverse events reported which have been attributed to the product lots being out-of-specification for preservative efficacy. Bausch + Lomb is recalling the lots of product in the interest of patient safety.
Bausch + Lomb has chosen to discontinue Murocel® Methylcellulose Lubricant Ophthalmic Solution because the company currently has products within its portfolio to treat the same symptoms for which Murocel® is indicated. Murocel® Methylcellulose Lubricant Ophthalmic Solution, USP 1% has been available for use in the United States for more than a decade. It is an over-the-counter ophthalmic solution indicated for the temporary relief of burning and irritation due to dryness of the eye.
Bausch + Lomb has directly contacted U.S. retailers who have been shipped this product to initiate the recall and inform them of the steps they should take to return the product. We have also contacted eye care professionals to alert them of the recall.
We are asking consumers who currently have product matching the affected lots of Murocel® Methylcellulose Lubricant Ophthalmic Solution, USP 1% to return the product to Bausch + Lomb. Even if consumers are comfortable using the solution, we urge them to return the product.
Consumers who have this product in their home should call our customer service center for instructions on returning and reimbursement: 1-800-553-5340. Bausch + Lomb’s customer service line is open to consumers 9am-5pm EST Monday through Friday.
AFFECTED PRODUCT DETAILS:
Lot Numbers and Expiration Dates:
LOT: 467061 EXP: 09-30-2011
LOT: 487551 EXP: 11-30-2011
LOT: 548051 EXP: 05-31-2012
LOT: 132171 EXP: 08-31-2012
LOT: 136571 EXP: 11-30-2012
LOT: 140181 EXP: 01-31-2013
UPC Code: 3 24208 28015 7
Case Code: (01)50324208280154(30)00144
Packaging and Dosage:
The product is packaged in a single, sterile 15ml bottle for use by consumers. It is dosed as one to two drops in the affected eye(s) as needed or directed by your doctor.
About Bausch + Lomb
Bausch + Lomb is one of the best-known and most respected healthcare companies in the world. Its core businesses include contact lenses and lens care products, ophthalmic surgical devices and instruments, and ophthalmic pharmaceuticals. Founded in 1853, the company is headquartered in Rochester, N.Y., and employs more than 10,000 people worldwide. Its products are available in more than 100 countries. More information is available at www.bausch.com.
Murocel® is a trademark of Bausch & Lomb Incorporated.
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