Archive for October, 2010
KOSHER FIRST LLC. 502 FLUSHING AVE. is recalling TUV TAAM SALADS NOVA LOX SALAD due to Listeria monocytogenes contamination. 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.
Tags: food safety
Oversulfated chondroitin sulfate (OSCS) contaminant found during sample testing.
Tags: MedWatch Safety Alerts
Building upon the extensive testing and protocols already in use by federal, state and local officials for the fishing waters of the Gulf, NOAA and FDA have developed and are using a chemical test to detect dispersants used in the Deepwater Horizon-BP oil spill in fish, oysters, crab and shrimp. Trace amounts of the chemicals used in dispersants are common, and levels for safety have been previously set.
Tags: fda press release
B. Braun Medical Inc. (B. Braun) was recently notified by its supplier, Scientific Protein Laboratories LLC (SPL), of a nationwide recall of a lot of Heparin Sodium USP Active Pharmaceutical Ingredient (API) sold to B. Braun because additional testing of retained crude heparin samples used by SPL to manufacture this single API lot indicated a trace amount of oversulfated chondroitin sulfate (OSCS) contaminant. As a result, B. Braun is initiating a voluntary recall of seven lots of heparin injection products to the healthcare provider level.
Tags: FDA Recalls
Potential to develop adverse reactions in areas where the particles lodge, which could result in serious adverse events, disability, or death.
Tags: MedWatch Safety Alerts
What can you do about colds and flu? FDA offers tips for prevention and treatment
Tags: Consumer Health Alerts
The U.S. Food and Drug Administration today approved Latuda (lurasidone HCl) tablets for the treatment of adults with schizophrenia.
Tags: fda press release
Sandoz Inc. announced today it has initiated a voluntary recall in the US of all 50mg/2mL and 250mg/10mL vials of Sandoz and Parenta brand Methotrexate Injection, USP product (“methotrexate”) to the consumer/user level. Consistent with its commitment to quality and patient safety, Sandoz is initiating this voluntary recall of all 24 lots of the affected product following the finding of small glass flakes by Sandoz quality control in a limited number of vials in four lots. The flakes are the result of delamination of the glass used to manufacture the vials of these two dosage presentations.
Tags: FDA Recalls
Sprycel, CML
Tags: fda press release