US Oftalmi Announces Voluntary Recall of the Camolyn Eye Drops Product Line, and Fisiolin Nasal Drops

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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Celeste Industries Corporation Recalls All Lots of simplySmart Remove Make Up Remover

Celeste Industries Corporation has voluntarily recalled all lots of simplySmart™ "Remove" Make Up Remover in the US and Canada This product is packaged as a single towelette with hiexpress.com shown on the packet. This recall was a result of certain limited lots testing positive for Pseudomonas aeruginosa bacteria.

The organism Pseudomonas aeruginosa may cause serious eye infections, respiratory infections, dermatitis, soft tissue infections, bacteremia, and a variety of systemic infections, particularly in patients who are immunosuppressed. Because the Make-Up Remover may be used in the area of the eye, there is a possibility that inadvertent introduction of the tainted product directly in the eye could result in serious eye infections.

No illnesses have been reported to date in connection with this problem. The issue was discovered after a consumer complained of an odor coming from the towelette packets.

This product is not sold in the retail market but is provided as a guest amenity at Holiday Inn Express® hotels in the United States in Canada.

Celeste Industries ceased production of the product on October 5, 2008 and subsequently notified the distributor and the Food and Drug Administration

Any hotel guests who may have taken the product are advised to not use the product and to destroy it immediately. Consumers who have used the product and have any concerns should contact a healthcare professional.

Celeste Industries has identified the source of the contamination and will take all necessary steps to prevent future contamination when production of the product is resumed.

Consumers with questions regarding the recall should contact Celeste Industries Corporation at 410-822-6200, ext 1349 between 8:00 a.m. and 5:00 p.m. EST and ask for Quality Assurance or e-mail at recall@celestecorp.com. This recall is being made in cooperation with the Food and Drug Administration.

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The Hartz Mountain Corporation Voluntarily Recalls One Specific Lot of Nationwide Chicken-Basted Rawhide Chips Because of Possible Health Risk

The Hartz Mountain Corporation, Secaucus, NJ is voluntarily recalling one specific lot of Hartz Chicken-Basted Rawhide Chips due to concerns that one or more bags within the lot are potentially contaminated with Salmonella. Hartz is fully cooperating with the US Food and Drug Administration in this voluntary recall.

Salmonella can cause serious infections in dogs, and, if there is cross-contamination caused by handling of the rawhide chips, in people as well, especially children, the aged, and people with compromised immune systems. Healthy people potentially infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. On rare occasions, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.

Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Animals can be carriers with no visible symptoms and can potentially infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.

The product involved is 4,850 - 2 pound plastic bags of Hartz Chicken-Basted Rawhide Chips, lot code JC23282, UPC number 3270096463 which were distributed to a national retail customer. While the normal testing that Hartz conducts through an independent outside laboratory did not detect the presence of Salmonella in any Hartz rawhide products, sample testing conducted by another laboratory did indicate the presence of the bacteria in a sample bag of the Chicken-Basted Rawhide Chips. Hartz is aggressively investigating the difference in test results and the potential source of the problem.

Although Hartz has not received any reports of animals or humans becoming ill as a result of coming into contact with this product, Hartz is taking immediate steps to remove the product from all retail stores and distribution centers. Dog owners who purchased this product should check the lot code on their bag, and, if the code is not visible, or if the bag has lot code JC23282 imprinted thereon, they should immediately discontinue use of the product and discard it in a proper manner.

Consumers can contact Hartz at 1-800-275-1414 with any questions they may have and to obtain reimbursement for purchased product.

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