B+L recalls drop

March 9, 2011

Make sure your patients know about Bausch + Lomb?s voluntary recall of all lots of an eye drop (Soothe Xtra Protection [XP]).

Madison, NJ-Eye-care professionals should alert patients about Bausch + Lomb’s voluntary recall of all lots of an eye drop (Soothe Xtra Protection [XP]).

The company already has contacted retailers and eye-care professionals about the recall. If your patients are using the product, advise them to stop and return the drops to the company. For instructions on returns and reimbursement, patients can call the Soothe Xtra Protection (XP) Hotline, 866/761-9526, or the Bausch + Lomb customer service center, 800/553-5340, which is open 9 a.m. to 5 p.m. ET weekdays.

The company issued the recall after testing showed that the preservative in specific lots (with expiration dates between February 2011 and August 2012) may not be effective for the product’s entire shelf life. Product that is out of specification near the end of shelf life may not adequately protect against inadvertent microbial contamination during storage and usage.

No adverse events have been reported. Potential adverse events include burning, stinging, eye redness, or eye discomfort.

The drop is available only in the United States. The company has alerted the FDA of the recall and is investigating why the specific lots were out of shelf-life specification.

Two other products in the same line (Soothe Preservative Free eye drops and Soothe Night Time Ointment) have not been recalled and remain available to your patients.