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.
|CAMOLYN PLUS, NAPHAZOLINE +
CHAMOMILE 15 ml.
|CAMOLYN REFRESH 15 ml.||116636
|CAMOLYN-A, NAPHAZOLINE +
PHENIRAMINE 15 ml
|FISIOLIN NASAL DROPS SODIUM
CHLORIDE PEDIATRIC USES 15 ml.