FDA product safety recall: US Oftalmi eye/nasal drops potentially unsterile
Legal News for Product Liability Attorneys. The FDA announced the recall of potentially unsterile eye and nasal drops manufactured by US Oftalmi.
News for product liability attorneys- Consumer safety hazards prompted recall of eye/nasal drops, FDA announced.
Hallandale, FL—US Oftalmi Corp., in cooperation with the U.S. Food and Drug Administration (FDA) http://www.fda.gov announced the voluntary recall of 15 mL plastic bottles of over-the-counter Camolyn Eye Drops and Fisiolin Nasal Drops. The FDA announced the recall on Friday, April 2, 2010 after it was discovered that the products be unsterile, subsequently posing safety hazards to consumers.
According to the FDA, the recall was issued “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”. Although the recalled products have yet to cause any injuries, illnesses or harmful effects, US Oftalmi issued the recall as a safety precaution. The chances of consumers suffering any unpleasant reactions from the recalled eye and nasal drops were reportedly deemed to be slim and unlikely, however, the firm did not want to take any chances with regard to the safety of the product. US Oftalmi has stopped production, importation and distribution of the recalled eye and nasal drops for the time being.
Product names, lot numbers, expiration dates, and UPC codes affected by the recall are listed below:
Lot #: 049036, 087934
Expiration dates: 05/2011, 08/2009
UPC codes: 591196, 00446
•CAMOLYN PLUS, NAPHAZOLINE + CHAMOMILE 15 ml.
Lot #: 037691, 097420
Expiration Dates: 03/2010, 10/2010
UPC codes: 66482, 00018
•CAMOLYN REFRESH 15 ml.
Lot #: 116636, 107610
Expiration Dates: 11/2009, 11/2010
UPC codes: 66482, 00020
•CAMOLYN-A, NAPHAZOLINE + PHENIRAMINE 15 ml
Lot #: 057063, 058962, 106606, 099487
Expiration Dates: 05/2009 ,04/2010, 10/2008, 09/2011
UPC codes: 66482, 00019
•FISIOLIN NASAL DROPS SODIUM CHLORIDE PEDIATRIC USES 15 ml.
Lot #: 028659
Expiration Dates: 03/2011
UPC codes: 591196, 00375
Consumers have been urged to discard affected eye and nasal drops immediately. US Oftalmi may be contacted at (954) 338-6891 from 8 a.m. to 4:30 p.m. EST Monday through Friday for more information concerning the product safety recall. According to US Oftalmi president, “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.”
Legal News Reporter: Sandra Quinlan- Legal News for Product Liability Lawyers.