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.
Category Archives: Food & Drug Recalls
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.
Working with FDA, Standard Homeopathic Company Voluntarily Recalls Hyland’s Teething Tablets to Address Manufacturing Process
Standard Homeopathic Company, in consultation with the U.S. Food and Drug Administration (FDA), is voluntarily recalling its Hyland’s Teething Tablets. The company is initiating this recall in an abundance of caution due to an FDA investigation of its manufacturing facility. Hyland’s Teething Tablets are manufactured in the United States and distributed throughout North America.
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.
Nestle® USA Issues Allergen Alert on Single Production Code of Nestle® Raisinets® Fun Size Bags
Nestle USA’s Confections & Snacks Division is initiating a voluntary recall of Nestle® RAISINETS® Fun Size Bags (10oz) with a production code of 02015748/UPC number 2800010255, which may contain undeclared peanuts. People who have allergies or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.
DSHS Orders Sangar Produce to Close, Recall Products
The Texas Department of State Health Services today ordered Sangar Fresh Cut Produce in San Antonio to stop processing food and recall all products shipped from the plant since January. The order was issued after laboratory tests of chopped celery from the plant indicated the presence of Listeria monocytogenes, a bacterium that can cause severe illness.
Western Milling LLC Voluntarily Recalls Universal Turkey and Kruse G.B. Turkey Grower Feeds Because of Possible Health Risk to Animals
Western Milling, LLC announced a voluntary recall of certain types of store brand noncommercial turkey feed after the company learned that the feed may contain monensin, a medication included in medicated turkey feed. The turkey feed subject to this voluntary recall was not labeled as medicated and was not formulated to contain monensin.
Foremost Foods International, Inc. Issues Recall on Certain Tomi Dried Seafood Products
Foremost Foods, International, Inc. of Pomona, CA, is issuing a voluntary recall on certain Tomi brand dried seafood products because they have the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled. The products were manufactured by Kien Long Seafood Company Ltd. of Vietnam.