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You are here: Home / Featured / US Oftalmi Recall the Camolyn Eye Drops Product Line and Fisiolin Nasal Drops

US Oftalmi Recall the Camolyn Eye Drops Product Line and Fisiolin Nasal Drops

April 8, 2010 By The FDA Leave a Comment

US Oftalmi has recalled all Over-the-Counter Eye Drops and Nasal Drops. Products are packaged in 15mL plastic bottles and were distributed nationwide to food and drug distributors for retail.

This recall is being initiated due to conditions at the manufacturing facility that cannot assure the sterility of the products. Products that are non-sterile have the potential to cause eye infections, which may be sight threatening.

No adverse effects, illness or injuries have been reported to date. Any adverse reactions associated with the use of these products may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at HYPERLINK “/Safety/MedWatch/default.htm”www.fda.gov/medwatch.1

The company has ceased the production, importation and distribution of the products until further notice. Consumers who may have any of these products on hand are advised to discard them immediately. Consumers with questions may call US Oftalmi at (954) 338-6891 Monday through Friday 8AM to 4:30 PM EST.

PRODUCT LOT# EXPIRATION
DATE
UPC
CAMOLYN HOMEOPATHIC 049036
087934
05/2011
08/2009
591196 00446
CAMOLYN PLUS, NAPHAZOLINE +
CHAMOMILE 15 ml.
037691
097420
03/2010
10/2010
66482 00018
CAMOLYN REFRESH 15 ml. 116636

107610

11/2009
11/2010
66482 00020
CAMOLYN-A, NAPHAZOLINE +
PHENIRAMINE 15 ml
057063

058962
106606
099487

05/2009
04/2010
10/2008
09/2011
66482 00019
FISIOLIN NASAL DROPS SODIUM
CHLORIDE PEDIATRIC USES 15 ml.
028659 03/2011 591196 00375

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About The FDA

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.

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