FDA NEWS

Trasylol (aprotinin injection)
Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses.

Cardinal Alcohol-Free Mouthwash
Additional lot recalled because of the presence of Burkholderia cepacia.

Blount Fine Foods Issues Allergy Alert On Undeclared Shrimp in All Natural New England Clam Chowder, 20 Oz Cup (May 6)
Blount Fine Foods is recalling Blount All Natural New England Clam Chowder, Net Wt. 20 oz with Lot: 0424086D, Sell by date: 6/23/2008, because it may contain undeclared shrimp. People who have an allergy or severe sensitivity to shrimp run the risk of serious or life-threatening allergic reaction if they consume these products. The firm has recovered 1,400 of 1,416 units produced, 16 units are in distribution.

Hydrox Labs Issued a Voluntary Recall of Alcohol-Free Mouthwash Nationwide Distributed by Cardinal Health (May 2)
Hydrox Labs has issued a voluntary recall of Cardinal Health labeled alcohol-free mouthwash. The mouthwash has been tested and been found positive for Burkholderia cepacia (B. cepacia). The CDC has confirmed hospital illnesses in one state associated with the use of the affected mouthwash.

Little Bay Baking Company Issues Nationwide Allergy Alert On Undeclared Soy In Corn Bread And Muffin Mix in 12.6 Ounce White Paper Tin Tie Bag Package (May 2)
Little Bay Baking Company of Newmarket, New Hampshire is recalling all bags of CORN BREAD AND MUFFIN MIX sold before May 2, 2008 because it contains undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.

Fine Land Corp Issues Alert on Undeclared Sulfites in Ying Feng Foodstuffs Brand Dried Bulbus Lily (April 11)
Fine Land Corp, 239 Bay 20th Street Brooklyn NY 11214, is recalling its Ying Feng Foodstuffs brand Dried Bulbus Lily because it contains undeclared sulfites.

Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products Used During Cardiopulmonary Bypass (May 7)
Medtronic, Inc. announced that it is initiating a voluntary and precautionary recall of selected products featuring the Carmeda BioActive surface. The affected devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs.

Heparin Sodium Injection
FDA requests that health professionals and facilities review and examine all drug/device storage areas to ensure that all recalled heparin products have been removed and are no longer available for patient use.

DPH Issues Consumer Warning for Chang Farm Soy Sprouts Because of Bacteria Contamination (April 23)
The Department of Public Health (DPH) is issuing a warning to the public not to consume any soy sprouts produced from Chang Farms in Whatley, Massachusetts because of the presence of bacteria called Listeria monocytogenes (L. monocytogenes).

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