The Maryland Department of Health and Mental Hygiene (DHMH) and local health departments are conducting an investigation of a cluster of seven E. coli O157 infections. There have been no deaths, although three of the seven cases have been hospitalized. A potential association exists with the consumption of unpasteurized Baugher’s apple cider.
Actavis Encourages Consumers to Return Fentanyl Transdermal System 25 mcg/h
Further to its previously announced voluntary recall of 18 lots of Fentanyl Transdermal System 25 mcg/hour C-II patches, Actavis is encouraging consumers to return any product in their possession from the October 21, 2010 recall.
Beaver Street Fisheries, Inc Voluntarily Recalls Tuna due to Possible Health Risk
Beaver Street Fisheries, Inc. of Jacksonville, FL is recalling 5-7 lb Tuna Loins Lot 928378, because they have the potential to be contaminated with elevated levels of histamine. High levels of histamine can produce an allergic reaction called scombroid poisoning when the fish is consumed
Intelli Health Products, Issues a Voluntary Nationwide Recall of Duro Extend Capsules for Men Marketed as Dietary Supplements
Intelli Health Products, announced today that it is conducting a voluntary nationwide recall of Duro Extend Capsules For Men. Intelli Health Products, is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that laboratory analysis of Duro Extend Capsules For Men sample found the product to be adulterated with Sulfoaidenafil, an analogue of sildenafil which is an FDA approved drug used in the treatment of Erectile Dysfunction(ED), making it an unapproved new drug.
FDA Classifies Previous Field Action of Medtronic Surgical Device as Class I Recall
Medtronic, Inc. (NYSE: MDT) today announced the U.S. Food and Drug Administration (FDA) has classified the company’s previous action related to the Octopus® Nuvo Tissue Stabilizer as a Class I recall. FDA classifies a recall as Class I when the agency believes that there is a reasonable probability that use of the recalled product will cause serious adverse health consequences or death.
Kosher First LLC. Issues Alert on Listeria in Tuv Taam Salads Nova Lox Salad
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.
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B. Braun Voluntarily Recalls Seven Lots of Heparin Manufactured in 2008 Due to Supplier-Initiated Recall of Heparin Active Pharmaceutical Ingredient (API)
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.
Sandoz initiates voluntary recall in the US of all 50mg/2mL and 250mg/10mL vials of Methotrexate Injection, USP due to the presence of glass particulates
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.
bioMérieux, Inc. Issues Urgent Product Correction for VITEK® 2 Gram Negative Susceptibility Cards Containing Piperacillin/Tazobactam
bioMérieux, Inc. on September 16, 2010, initiated a worldwide voluntary product correction of VITEK® 2 Gram Negative Susceptibility Cards containing the antibiotic Piperacillin/Tazobactam (TZP). These cards, manufactured after March 10, 2009, are used in clinical laboratories to perform antimicrobial susceptibility testing as part of the VITEK® 2 System.
Mega Pops Manufacturer Leads Effort with Retailers to Recall Product Voluntarily During Review of Customer Concerns
A limited number of Mega Pops™ brand lollipops may contain traces of foreign particles, and as a precautionary measure, manufacturer Colombina S.A. is asking customers to return these lollipops to their retailer and instructing retailers to recall the product voluntarily. Colombina believes the product presents no health risk.