US Oftalmi of Hallandale, Florida, is recalling its entire Camolyn Eye Drops Product Line, as well as Fisiolin Nasal Drops. The recall was issued because of 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. Based on its investigation to date, US Oftalmi believes the likelihood of users experiencing a serious adverse reaction is remote.
However, the company is taking a conservative approach and is conducting the recall in the best interest of its customers. This recall is being made with the knowledge of the Food and Drug Administration.
Importation and distribution of the products until further notice
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.
The products subject to this recall include:
CAMOLYN HOMEOPATHIC with UPC #591196 00446
Lot #049036, Expiration Date: 05/2011
Lot #087934, Expiration Date: 08/2009
CAMOLYN PLUS, NAPHAZOLINE + CHAMOMILE 15 ml. with UPC #66482 00018
Lot #037691, Expiration Date: 03/2010
Lot #097420, Expiration Date: 10/2010
CAMOLYN REFRESH 15 ml. with UPC #66482 00020
Lot #057063, Expiration Date: 05/2009
Lot #058962, Expiration Date: 04/2010
Lot #106606, Expiration Date: 10/2008
Lot #099487, Expiration Date: 09/2011
FISIOLIN NASAL DROPS SODIUM CHLORIDE PEDIATRIC USES 15 ml. with
UPC #591196 00375
Lot #028659, Expiration Date: 03/2011