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Oftalmi Product Recall

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US Oftalmi Corp. has 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 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.

Here are the products:

?CAMOLYN HOMEOPATHIC

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

Full post as published by A Georgia Lawyer on April 13, 2010 (boomark / email).