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U.S. Oftalmi Recalls Camolyn Eye Drops, Fisiolin Nasal Drops

Last Updated: April 08, 2010.

 

Because of conditions at manufacturing facility, the products have potential to be non-sterile

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The U.S. Food and Drug Administration and U.S. Oftalmi have notified health care professionals of a nationwide voluntary recall of over-the-counter Camolyn eye drops and Fisiolin nasal drops.

THURSDAY, April 8 (HealthDay News) -- The U.S. Food and Drug Administration and U.S. Oftalmi have notified health care professionals of a nationwide voluntary recall of over-the-counter Camolyn eye drops and Fisiolin nasal drops.

U.S. Oftalmi, which manufactures the products, has initiated the recall because it cannot ensure the products' sterility due to conditions at the manufacturing facility. Non-sterile products have the potential to cause eye infections, which could threaten sight. The recall includes all lots of 15 mL bottles. In a news release, the company says that no adverse events have been reported to date and that it believes the chance of individuals experiencing serious adverse reactions is remote.

In addition to the recall, the company has stopped production, distribution and importation of these products. The FDA is encouraging patients and health care professionals to report adverse events or side effects related to the products to the agency's MedWatch Safety Information and Adverse Event Reporting Program.

Corrado Ruscica, Oftalmi's president, said in a statement that "the company is committed to taking all necessary measures to remedy these production issues, and protect the trust physicians and patients place in our products."

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