Ventlab LLC. of Grand Rapids, Michigan has initiated a voluntary medical device removal of a limited number of Ventlab™ Resuscitator Bags after becoming aware of complaints regarding a sticking duckbill valve that resulted in the resuscitation bags delivering no air through the patient valve, to the patient. The valves may stick due to incomplete curing during the manufacturing process.
U.S. Marshals seize unapproved drugs from Ohio distributor
U.S. Marshals, at the request of the U.S. Food and Drug Administration and the U.S. Attorney for the Southern District of Ohio, have seized more than $11,185,000 worth of unapproved drugs marketed by Ascend Laboratories of Montvale, N.J. and distributed by Masters Pharmaceuticals, Inc. of Cincinnati, Ohio.
FDA requiring lower starting dose for sleep drug Lunesta
The U.S. Food and Drug Administration today announced it required the manufacturer of the sleep drug Lunesta (eszopiclone) to change the drug label and lower the current recommended starting dose. Data show that eszopiclone levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving, even if they feel fully awake.
Bravo® Issues Nationwide Recall of Pet Food for Dogs and Cats
Manchester, CT – Bravo is recalling select lots and product(s) of Bravo Pet Food because they have the potential to be contaminated with Listeria monocytogenes.
Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Hospira Announces Voluntary Nationwide Recall Of One Lot Of Dobutamine Injection, USP, 250 MG, 20 ML, Single-Dose Fliptop Vial, Due To Visible Particulates
May 14, 2014 – Hospira, Inc. (NYSE: HSP), on Jan. 10, 2014, issued a nationwide recall to the user level for one lot of Dobutamine Injection, USP, 250 mg, 20 mL, Single-dose fliptop vial, (NDC 0409-2344-02), Lot 27-352-DK. (NDC and lot number can be found on the right-hand side of the primary label).
US Trading Company Voluntary Recall of Crushed Chili Powder Because of Possible Health Risk
US Trading Company of Hayward, CA is recalling its Dragonfly Brand Crushed Chili Powder in 6.3 ounce plastic tubs with lot code 359XP, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Surma Distributors LLC, Issues Alert On Undeclared Sulfites In Haque Brand Golden Raisins
Surma Distributors LLC., located at 1075 Flushing Ave., Brooklyn, NY 11237, is recalling HAQUE brand Golden Raisins because the product contains undeclared sulfites.
Domega Ny International Co Ltd Issues Allergy Alert On Undecleared Eggs In Brilliant Cake With Filling Milk (biscuits)
recalling BRILLIANT CAKE WITH FILLING MILK (BISCUITS) because it contains undeclared eggs. Consumers who have allergies to eggs run the risk of serious or life-threatening allergic reactions if they consume this product.
FDA allows marketing of first prosthetic arm that translates signals from person’s muscles to perform complex tasks
The U.S. Food and Drug Administration (FDA) today allowed marketing of the DEKA Arm System, the first prosthetic arm that can perform multiple, simultaneous powered movements controlled by electrical signals from electromyogram (EMG) electrodes.
Domega NY International Co LTD Issues Allergy Alert On Undeclared Peanuts In YF Sesame Flavor Cracker
DOMEGA NY INTERNATIONAL CO LTD, 47-57 BRIDGEWATER STREET BROOKLYN NY 11222 is recalling YF Sesame Flavor Cracker because it contains undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reactions if they consume this product.