Safety Alerts & Recalls
What does this mean?
No adverse effects, illness or injuries from the Camolyn products have been reported to date. The manufacturer believes the risk of users experiencing a serious adverse reaction is very low. However, the company is taking a conservative approach and is conducting the recall in the best interest of its customers.
Consumers who may have any of these products on hand are advised to throw them away immediately. If you have any questions, you may call the company US Oftalmi at (954) 338-6891 Monday through Friday 8AM to 4:30 PM EST.
If you think you are experiencing side effects from a recalled Camolyn product, please follow up with your doctor. Health care professionals and consumers are encouraged to report adverse events that may be related to the use of these products to the FDA's MedWatch Program by phone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
Oftalmi Announces Recall of the Camolyn Eye Drops Product Line
US Oftalmi is conducting a voluntary nationwide recall of all Over-the-Counter Eye Drops and Nasal Drops. Products were packaged in 15 mL plastic bottles and were distributed nationwide to food and drug distributors for retail. These products are being recalled because conditions at the manufacturing facility cannot assure the sterility of the products. Products that are non-sterile have the potential to cause eye infections, which may affect the sight.
The following products and lot numbers are being recalled: Camolyn Homeopathic - Lots 049036 and 087934
Camolyn Plus, Naphazoline + Chamomile 15 mL - Lots 037691 and 097420
Camolyn Refresh 15 mL - Lots 116636 and 107610
Camolyn-A, Naphazoline + Pheniramine 15 mL - Lots 057063, 058962, 106606, and 099487
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