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Cytosol recalls balanced salt solution upon FDA request
An FDA investigation found elevated levels of endotoxin in saline product lots, contrary to Cytosol’s previous claims of product safety.
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Cytosol Ophthalmics has recalled all of its balanced salt solution following a request from the Food and Drug Administration, the company recently announced.
The recall came after the FDA announced on its Web site that an onsite investigation found that product lots had elevated levels of endotoxin, a substance found in certain bacteria that can cause severe reactions including fever, shock and changes in blood pressure and other circulatory functions.
On Feb. 15, Cytosol issued a letter to all of its customers informing them of the recall, which included all lots of 500 mL glass bottles and plastic bottles of the solution, as well as 18 mL plastic bottles, 250 mL plastic bottles and 200 mL glass bottles of the solution.
“This letter is to inform you that Cytosol Laboratories Inc., is voluntarily recalling all balanced salt solution manufactured in their facility in Braintree, Massachusetts,” the letter read.
The Cytosol Labs products subject to the recall were distributed under three labels: AMO Endosol (Advanced Medical Optics), Cytosol Ophthalmics (Cytosol) and Akorn (Akorn).
AMO issued a voluntary recall of its Endosol product on Nov. 18, 2005, after receiving reports of toxic anterior segment syndrome (TASS), a serious and sometimes irreversible noninfectious inflammation of the eye.
With sales of Cytosol’s balanced salt solution accounting for approximately 85% of the company’s total sales, the effects of the recall will be difficult to recover from, according to company officials.
“[The recall] is devastating,” Cytosol President Court Lewis told Ocular Surgery News during a phone interview.
The FDA statement said it estimated that 1 million units of balanced salt solution products were distributed over a 2-year span from December 2003 to December 2005.
The company is currently focused on recalling what Mr. Lewis estimated to be 1.5 million units of balanced salt solution, but he said that they have hope that they can recover the integrity of their product and reestablish a supply.
“We certainly see some challenges there, but we’ll certainly attempt to do that,” he said.
FDA involvement
Cytosol’s recall letter came two days following the FDA’s announcement requesting that Cytosol recall any and all brands and sizes of balanced salt solution that the company manufactures.
The FDA letter was delivered to Cytosol on Feb. 13, according to information posted on the FDA Web site.
“The FDA requests that the company take immediate action to retrieve all inventories of the product, including any existing stock at physician offices and hospitals,” the statement said.
In addition, the FDA asked hospitals, physicians and consumers to stop using any balanced salt solution products from Cytosol immediately and to quarantine the remaining product. The notice explained that if no instructions for returning the product were received from Cytosol, the product should be destroyed.
Due to the ongoing nature of the FDA’s investigation, the agency was unable to comment for this article on the specifics of what they found at the manufacturing plant. But according to its Web site announcement, in addition to reports of TASS, the FDA said it received complaints related to injuries in more than 300 patients who received balanced salt solution manufactured by Cytosol.
In a statement on the Cytosol Web site dated Feb. 18, Mr. Lewis said that Cytosol received only two complaints of TASS after cataract surgery in which its balanced salt solution was used, and he said that the two complaints involved only five patients, two at one center and three at another.
He said that the reactions occurred between July and October of 2005, after which no further reports were issued.
“We did not receive a single additional complaint from October to Feb. 10, 2006,” the statement said.
Delayed recall
AMO initially recalled its Endosol product when the complaint department received reports of TASS from approximately 30 accounts. This action was reported in Ocular Surgery News Jan. 15, 2006 issue, page 20.
At the time that AMO elected to voluntarily recall their product, Cytosol continued to ship the balanced salt solution.
In his Feb. 18 statement, Mr. Lewis explained that he personally chose not to recall the product in November due to the fact that the company’s initial testing confirmed the product’s safety.
“We utilized the ‘referee test’ for endotoxin as described in the United States Pharmacopeia,” he wrote. “Our testing method was audited by the FDA in November 2005 and no deficiencies were noted.”
His statement also said that from October 2005 to January, Cytosol retested the irrigation products for endotoxin more than 2,000 times and found no units above the 0.25 limit.
AMO has ended its business ties with Cytosol and has begun using Baxter as its balanced salt solution supplier, according to AMO spokesperson Steve Chesterman.
In the Feb. 18 statement, Mr. Lewis told the ophthalmic community to continue to monitor the Cytosol Web site for updates on the product recall.
For Your Information:
- Court Lewis is the president of Cytosol Ophthalmics. He can be reached at Cytosol Ophthalmics-Lenoir Inc., P.O. Box 1408, 1325 William White Place NE, Lenoir, NC 28645; 800-234-5166 or 828-758-2343; fax: 828-758-2345; e-mail: clewis@cytosol.com.
- Steve Chesterman can be reached at Advanced Medical Optics Inc., 1700 E. St. Andrew Place, P.O. Box 25162, Santa Ana, CA 92799-5162; 714-247-8711; e-mail: steve.chesterman@amo-inc.com.
- The Food and Drug Administration can be reached at 5600 Fishers Lane, Rockville, MD 20857; 888-463-6332.
- Jared Schultz is an OSN Staff Writer who covers all aspects of ophthalmology. He focuses geographically on Europe and the Asia-Pacific region.