Novartis Ophthalmics AG Recalls Seven Lots Of GenTeal(R) Products In The US
EAST HANOVER, N.J., Nov. 16 /PRNewswire/ -- Novartis Ophthalmics announced today it has voluntarily recalled a total of seven lots of two products intended for use in the eye. Novartis Ophthalmics takes its mission of patient care and providing quality products very seriously, and therefore, believes it is necessary to take this precautionary action. The recalls are being conducted with the knowledge of the FDA.
Novartis Ophthalmics is recalling five lots of GenTeal(R) Gel, a non-prescription drug product used to relieve dryness of the eye.
The five lots of GenTeal(R) Gel being recalled are: Lot #Z12468, 10 ml, expiration date 01/2006; Lot #Z12912, 3.5 ml, expiration date 03/2006; Lot #Z12900, 10 ml, expiration date 04/2006; Lot #Z13161, 10 ml, expiration date 05/2006; and Lot #Z13314, 3.5 ml, expiration date 06/2006. The five lots include about 142,500 tubes that were distributed nationwide from March to November 2004.
The GenTeal(R) Gel recall is being conducted following concerns regarding sterility of the product made for Novartis by a contract manufacturer. Additional sterility tests were conducted on several lots of GenTeal(R) Gel. Test results indicated the presence of mold in a small number of samples, leading Novartis to initiate a recall of the five lots. The species of mold that is suspected is generally not harmful, but has the potential to cause an eye infection in susceptible people, especially in those with compromised immune systems.
Novartis Ophthalmics is also recalling two lots of GenTeal(R) GelDrops. The two lots are Lot #51139, 15 ml, expiration date 07/2007; and Lot #51283, 25 ml, expiration date 07/2007. The two lots include about 12,000 dropper bottles that were distributed nationwide in October 2005.
The GenTeal(R) GelDrops lots are being recalled due to a lack of sterility assurance. While the risk of potential contamination is believed to be very low, contaminated product could cause infections in susceptible people, and Novartis initiated the recall as a precautionary measure. The sterility assurance issues have been corrected. Only the two distributed GenTeal(R) GelDrops lots are affected.
Consumers who have purchased GenTeal(R) Gel or GenTeal(R) GelDrops with any of these lot numbers should contact Novartis Ophthalmics at 1-866-393-6336.
The foregoing press release contains certain forward-looking statements that can be identified by terminology such as "potential," "could cause," or similar expressions, or by express or implied discussions regarding any potential revenue impact from the recall and manufacturing issues which are the subject of this release. Such forward-looking statements involve known and unknown risks, uncertainties or other factors that may cause the actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements. In particular, management's expectations could be affected by, among other things, uncertainties relating to the recall process; unexpected regulatory actions or delays or government regulation generally; continued unexpected manufacturing difficulties with respect to GenTeal(R) Gel or GenTeal(R) GelDrops; as well as other risks and factors referred to in the Company's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Novartis Ophthalmics
Novartis Ophthalmics, a business unit of Novartis Pharmaceuticals Corporation, is a global leader in research, development and manufacturing of leading ophthalmic pharmaceuticals that assist in the treatment of age-related macular degeneration, eye inflammation, glaucoma, ocular allergies and other diseases and disorders of the eye. Novartis Ophthalmics products are available in more than 110 different countries. Novartis Ophthalmics products are made in Switzerland, France, the United States and Canada. For more information, visit http://www.novartisophthalmics.com or http://www.us.novartisophthalmics.com.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG , a world leader in pharmaceuticals and consumer health. In 2004, the Group's businesses achieved sales of USD 28.2 billion and pro forma net income of USD 5.6 billion. The Group invested approximately USD 4.1 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 91,700 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
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