Today the U.S. Food and Drug Administration issued a proposed rule and draft special controls guidance lowering the risk classification for external pacemaker pulse generators from Class III (high-risk) to Class II (moderate-risk).
Category Archives: Food & Drug Recalls
Kroger Recalls Select Containers of Private Selection Extreme Moose Tracks Ice Cream for Undeclared Allergen
The Kroger Co. (NYSE: KR) said today it is recalling select containers of Private Selection Extreme Moose Tracks Ice Cream sold in 10 states because it may contain peanuts not listed on the label. Customers should return the product to stores for a full refund or replacement.
FDA approves Ferriprox to treat patients with excess iron in the body
The U.S. Food and Drug Administration today approved Ferriprox (deferiprone) to treat patients with iron overload due to blood transfusions in patients with thalassemia, a genetic blood disorder that causes anemia, who had an inadequate response to prior chelation therapy.
River Ranch Recalls Products Because of Possible Health Risk
River Ranch Fresh Foods, LLC of Salinas, CA is initiating a voluntary recall of 2,154 cases of various bagged salad products due to the potential of being contaminated with Listeria monocytogenes following a routine random test conducted by the Ohio Department of Agriculture.
CooperVision Continues the Voluntary Recall of Avaira™ Toric Contact Lenses
In full cooperation with the United States Food and Drug Administration, CooperVision, Inc. is continuing to work with the FDA, distributors, customers, eye care practitioners and lens wearers to complete the worldwide recall initiated on August 19, 2011 on certain lots of Avaira™ Toric contact lenses.
Media Statement on Voluntarily Recall of Giant Eagle Farmer’s Market Shredded Iceberg Lettuce
Giant Eagle has been informed by representatives of the Food and Drug Administration (FDA) of the presence of listeria monocytogenes in a routine random sample test of Giant Eagle Farmer’s Market eight ounce package of Shredded Iceberg Lettuce, produced by River Ranch Fresh Foods LLC, with a use by date of October 14,2011 (see attached product image). To date, there are no reported cases of customer illness due to consumption of this item.
Osamu Corporation Recalls Frozen Ground Tuna
Osamu Corporation of Gardena, CA is recalling up to 1,800 cases, lot# 7013, of frozen ground tuna because the FDA found decomposition in several samples of the product and also found elevated histamine levels in samples taken from one retail location. Osamu Corporation is recalling the product in an abundance of caution since decomposed product may promote formation of histamine.
NOW Foods Issues Voluntary Recall of Brewer’s Yeast Tablets
NOW Foods is voluntarily recalling selected lots of its
Brewer’s Yeast Tablets (Product Code 2410 and 2412) due to the presence of an undeclared
milk allergen. People who have an allergy or severe sensitivity to milk run the risk of a serious or
life-threatening allergic reaction if they consume these products and should stop taking them
immediately.
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FDA: U.S. Marshals seize foods stored at Washington State facility
At the request of the U.S. Food and Drug Administration, U.S. Marshals seized food products held at the food storage and processing facility of Dominguez Foods of Washington, Inc., in Zillah, Wash., on Sept. 30, 2011.
CFE International Fish Exporters Issues Alert on Uneviscerated Salted, Smoked, Split Herring Lot Code: 1171, Plant Registration #2406
CFE International, Canadian Fish Exporters, Inc. Auburndale, MA is recalling Salted, Smoked, Split Herring, , Lot Number: 1171, Plant Code: 2406 Producer: Leslie Leger & Sons, Ltd. Cap Pele, NB, Canada. A routine sample collected at a retail store by New York State Department of Agriculture and Markets found the product to be uneviscerated. Clostridium botulinum spores are more likely to be concentrated in the viscera than any other portion of the fish.