US Oftalmi, of Hallandale, Florida, announced today that it is conducting a voluntary nationwide recall of 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.
| 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 |
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.
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.
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.
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, said Corrado Ruscica, president. Products have been used safely since their introduction in 2004 and are supported by our 30-year heritage of meeting high safety and efficacy standards. US Oftalmi Corporation remain committed to product quality, integrity, and customer satisfaction.
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