Vitaflo USA Recalls Renastart 14.11 oz (400g) Cans Batch Number 12832

February 1, 2012

Vitaflo USA is recalling Renastart 14.11 oz (400g) cans, Batch Number 12832 (shown on underside of can), because some of the product shipped throughout the United States during the period December 29, 2011 through January 26, 2012 has been incorrectly labeled.
Renastart is a powdered medical food used in the dietary management of pediatric renal disease, for patients one year and older in the United States.  All other Vitaflo products, including Renastart cans in batches other than 12832 and Renastart packed in sachets, are not affected in any way. Some immediate consequences of using the incorrectly labeled product may result in high potassium blood levels (hyperkalemia) or high sodium levels in the blood (hypernatremia).  In most cases, symptoms may be hard for an individual to detect, but can result in significant health consequences potentially leading to death, which is the importance for contacting a health care professional. Longer term consequences can result in increased levels of calcium, phosphorus, and protein. There have been no cases of illness or other adverse effects reported to Vitaflo USA.
Following a customer complaint regarding the way the product was dissolving, Vitaflo determined that a small number of cans of a different product may have been wrongly labeled as Renastart.  The company is investigating to make sure we continue to safely meet the needs of our patients and as a precautionary measure has issued this immediate voluntary recall. Vitaflo USA is urging anyone who has any Renastart 14.11oz (400g) cans Batch Number 12832 to immediately stop using the product and to contact Vitaflo to arrange return of the product, at Vitaflo’s expense.  All patients who have consumed any Renastart from this batch should contact their health care professional immediately to determine next steps, including nutritional management alternatives.
Renastart 14.11oz (400g) product in cans is sold only in the United States. This product is not sold under any other name. Anyone who has Vitaflo’s Renastart 14.11oz (400g) cans Batch Number 12832 is urged to contact Vitaflo at 888-848-2356.  Vitaflo has extended its hours of availability through this toll-free number to 24 hours a day, seven days a week to answer any questions health care professionals and patients may have in addressing this situation.  Patients should always contact their health care professional.  Vitaflo is dedicated to serving the metabolic community through innovative and specialized medical food solutions for the nutritional management of rare metabolic disorders, pediatric renal disease and disease related malnutrition. Vitaflo USA products are sold to pharmacists, hospitals and home health providers. They are not available to retail customers without a prescription. More information can be found on www.vitaflousa.com.

Aveeno Baby Calming Comfort Lotion – Johnson & Johnson Baby Lotion – Bacteria

January 31, 2012

Johnson & Johnson has recalled one lot of Aveeno® Baby Calming Comfort Lotion in  in nine states.

This recall is being initiated as a precautionary measure after testing of a product sample by the FDA. That test indicated that the lot exceeded the specifications for common bacteria, though extensive testing by an independent laboratory afterward did not show that specifications were exceeded. However, Johnson & Johnson Consumer Companies, Inc. has voluntarily initiated this recall out of an abundance of caution. This action is not being undertaken on the basis of adverse events and the potential for adverse health effects is remote. Other lots of Aveeno Baby Lotion are not affected by this recall and remain available.

FDA Classifies Riata and Riata ST Silicone Defibrillation Leads as Class I Recall

December 16, 2011

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that the U.S. Food and Drug Administration (FDA) has classified its voluntary medical device advisory letter to physicians from Nov. 28, 2011, regarding the performance of Riata® and Riata® ST Silicone Defibrillation Leads, as a Class I Recall.

The classification of this recall is part of the process that follows any medical device advisory issued by a device manufacturer to physicians. The FDA’s classification updates the recommendations provided in the Nov. 28, 2011 Physician Advisory Letter, which is available on the company’s website, www.sjmprofessional.com. An estimated 79,000 Riata and Riata ST family of silicone leads remain active in patients in the U.S. The company stopped distributing the Riata and Riata ST family of silicone leads in December 2010. The affected model numbers are the Riata (8F) Silicone Endocardial Defibrillation Leads (Models 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, and 1592), and the Riata ST (7Fr) Silicone Endocardial Defibrillation Leads (Models 7000, 7001, 7002, 7010, 7011, 7040, 7041, and 7042).

Caribbean Rum Balls Issues Allergy Alert On Undeclared Allergens In Rum Balls

November 24, 2011

Caribbean Rum Balls of St. Thomas, VI, is issuing this alert due to undeclared allergens, specifically: wheat, coconut, milk, eggs and sodium bisulfite (preservative). People who have allergies to any of these ingredients run the risk of serious or life-threatening allergic reaction if they consume these products.The “Rum Balls” were distributed locally in retail stores and through mail orders.The product comes in 4, 8 and 12 ounce, white packages with the Caribbean Rum Balls name and logo.No illnesses have been reported to date in connection with this problem.The alert was initiated after it was discovered that the allergen-containing products were distributed in packaging that did not reveal the presence of allergens. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company’s production and packaging processes.All products are being re-labeled with new ingredient listings, including sub-ingredients and citing allergens.Consumers with questions may contact the company at 1-340-775-6616.

 

CooperVision Expands Recall of Avaira Line of Contact Lenses

November 17, 2011

CooperVision is expanding its worldwide recall of the Avaira brand product line of contact lenses to include a limited number of lots of Avaira Sphere contact lenses. In continued collaboration with the FDA, CooperVision is expanding the recall because it identified certain lots of Avaira Sphere lenses that did not meet its updated quality requirements due to the level of a silicone oil residue.

American Regent Recalls 17 Lots of Vasopressin Injection, USP, Multiple Dose Vials Due to Sub-Potency

August 9, 2011

American Regent, Inc. is recalling 5 lots of Vasopressin Injection, USP 20 units/mL (200 units/10mL), 10 mL Multiple Dose Vials; 11 lots of Vasopressin Injection, USP 20 units/mL, 1 mL Multiple Dose Vials; and 1 lot of Vasopressin Injection, USP 10 units/0.5 mL, 0.5 mL Multiple Dose Vials to the Retail/Hospital level.
American Regent, Inc.  has recalled these Vasopressin products because some vials may not maintain potency throughout their shelf-life.

Potential adverse events after administration of solutions that are below potency limits may include reduced effectiveness. American Regent, Inc. has received no reports of adverse events related to reduced effectiveness for Vasopressin Injection, USP of the lots being recalled during the time period January 1, 2009 to July 27, 2011.Vasopressin Injection, USP is indicated for prevention and treatment of postoperative abdominal distention, in abdominal roentgenography to dispel interfering gas shadows, and in diabetes insipidus.

Purina Recalls Limited Number of Purina ONE Vibrant Maturity 7+ Dry Cat Food Bags

July 31, 2011

Nestlé Purina PetCare Company (NPPC) has recalled a limited number of 3.5- and 7-pound bags of its Purina ONE Vibrant Maturity 7+ Dry Cat Food from a single production run and shipped to customers in 12 states in December 2010.  This is being done because some bags of the product have been found to be contaminated with Salmonella.  Only Purina ONE Vibrant Maturity 7+ Dry Cat Food with both the “Best By” date and the production code shown are included in this voluntary recall :

Product Name

McNeil Consumer Healthcare Recalls One Lot Of TYLENOL® Extra Strength Caplets 225 Count

July 6, 2011

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling at the retail level one product lot (60,912 bottles) of TYLENOL®, Extra Strength Caplets, 225 count bottles, distributed in the U.S. The recalled product was manufactured in February, 2009. McNeil is taking this action following a small number of odor reports, including musty, moldy odor. The uncharacteristic musty, moldy odor has been linked to the presence of trace amounts of a chemical known as 2,4,6-tribromoanisole (TBA).

Kashi Recalls Select Frozen Pizzas Due to Possible Plastic Fragments in Pizza Crust

June 7, 2011

Kashi recalls pizzas due to possible plastic fragments in pizza crust.  The recalled pizzas include the Mediterranean Thin Crust Pizza, Roasted Vegetable Thin Crust Pizza, and Mushroom Trio and Spinach Thin Crust Pizza.  Approximately 11,000 cases of frozen pizzas have been affected by the recall.

The following individually packaged pizzas have been recalled:

Global Wellness Recalls Via Xtreme Ultimate Sexual Enhancer Dietary Supplement For Men Due to Presence of Undeclared Drug

June 7, 2011

Global Wellness, LLC.  Of Hollywood, FL recalls Via Xtreme Ultimate Sexual Enhancer Dietary Supplement for Men due toundeclared drug ingredients.

The product was distributed throughout the U.S. Puerto Rico, and Canada to internet and retail consumers. The product is distributed as a bottle containing six (6) blue colored capsules per package. The label on the packaging lists the company name Global Wellness, LLC, Hollywood Florida. Only Lots 809013 and 806030 are covered in this recall.

Simply Thick Recalls Certain SimplyThick® Thickening Gel Products

June 5, 2011

Simply Thick, LLC has recaled SimplyThick® thickening gel products manufactured at a food processing plant located in Stone Mountain, Georgia since June 1, 2009. This plant is currently owned and operated by Thermo Pac, LLC. This voluntary recall is limited to only those products manufactured at the Stone Mountain, Georgia plant. Simply Thick products manufactured at two additional food processing plants are not subject to this voluntary recall.

For information on how to identify the products subject to this voluntary recall, please see the section below: How To Determine If The Product Was Manufactured At The Stone Mountain GA Plant.

Churchill Medical Systems, A Vygon Company, Skin-Prep Wipes used in Convenience Kits

June 4, 2011

Churchill Medical Systems is recalling certain lots of 5 hospital-use convenience kits. These products contain Skin-Prep Wipes that were affected by an April 2011 recall initiated by Smith & Nephew due to the potential for bacterial contamination.
The Skin-Prep Wipes were manufactured in the same facility as The Triad Group’s affected products. Testing was conducted by Smith & Nephew on product lots distributed and in quarantine and no contamination has been found to date. No injuries have been reported to Vygon as a result; however, Vygon is initiating this recall out of an abundance of caution as use of contaminated Skin-Prep Wipes could lead to life-threatening infections, especially in at risk populations, including immune suppressed and surgical patients. FDA has been apprised of this action. The convenience kits were shipped to distributors and hospitals between September 3, 2010 and March 11, 2011. Consumers who have the following product lots of the 5 convenience kits named below should cease use and coordinate the return and replacement of product with Vygon immediately.

Aidapak Services Recalls All Repackaged Pharmaceutical Drugs

June 3, 2011

Aidapak Services, LLC is recalling all of the products listed on their website after learning of the potential cross contamination of non-penicillin drug products repackaged in the same facility. There is potential likelihood that a serious anaphylactic reaction in patients, with known hypersensitivity to beta-lactam or penicillin products, could result from receiving these products. This poses potential serious risk to a patient’s health.

Globe All Wellness Recalls Dietary Supplement: Undeclared Drug

May 25, 2011

 

Contact: Consumer (954) 922-1133:

FOR IMMEDIATE RELEASE – May 24, 2011 – Globe All Wellness, LLC has been informed by the Food and Drug Administration (FDA) that one of the company’s weight loss dietary supplements that was sold by a seller that was not authorized by Globe All Wellness, LLC to sell the product contains an undeclared drug ingredient. FDA lab analyses of this dietary supplement was found to contain undeclared Sibutramine. The FDA has not approved Sibutramine; therefore the safety and effectiveness of this product is unknown.

Recall of Infant and Neonatal-Sized FilterLine H Set and VitaLine H Set Sampling Lines

May 21, 2011

 

Contact: Steve Kelly Phone: +1 (425) 487-7479 E-mail: steve.kelly@philips.com Ian Race Phone: +1 (978) 659-4624 E-mail: ian.race@philips.com

FOR IMMEDIATE RELEASE – May 20, 2011 – Philips recently recalled specific lots of infant and neonatal-sized Philips FilterLine H Set and VitaLine H Set Microstream carbon dioxide (CO2) sampling lines shipped from November 2010 through March 2011.

American Regent Recalls Sterile Water for Injection, USP 50 mL Single Dose Vial Due to Particulate Matter

May 21, 2011

 

Contact

Walter Tozzi, R.Ph., M.S., M.B.A Sr. Director of Professional Services 631-924-4000

FOR IMMEDIATE RELEASE – May 19, 2011 – Shirley, NY – American Regent is conducting a nationwide voluntary recall to the consumer and user level of the following product:

Phoenix Import & Distribution Recalls Pentrexyl Forte Natural

May 21, 2011

 

Contact: Consumer: Gus Guevara 281-288-9838

FOR IMMEDIATE RELEASE – May 19, 2011 – Phoenix Import & Distribution LLC recalls PENTREXYL FORTE NATURAL because the packaging is believed to be misleading, causing it to be confused with an antibiotic. The product is packaged in a green and white box, containing 30 red and white capsules. PENTREXYL FORTE NATURAL is a Dietary Supplement only and does not contain antibiotics. Use of the product by ill individuals could delay treatment for serious illnesses.

Multi-Mex Distributor Recalls Dietary Supplements Labeled as Antibiotics

May 10, 2011

Multi-Mex Distributor, Inc., Tucker, GA is recalling dietary supplements that may be labeled as antibiotic drugs.

The products were distributed in the following states: Georgia, Tennessee, California, Illinois, Texas, North Carolina, South Carolina, Colorado, and Indianapolis, to the retail store and distributors.

The following products are being recalled:

American Regent Recalls Caffeine & Sodium Benzoate Injection, USP 250 mg/mL, 2 mL Single Dose Vial Due to Visible Particulates

May 6, 2011

Shirley, NY – American Regent is conducting a nationwide voluntary recall to the consumer and user level of the following product: Caffeine & Sodium Benzoate Injection, USP, 250 mg/mL, 2 mL Single Dose Vial,
NDC # 0517-2502-10, Lot #0084,  Exp Date  February, 2012.

Defibtech Recalls DDU-100 series AEDs: Automatic External Defibrillators (AED)

May 3, 2011

Recalled Defibtech AEDDefibtech, LLC has recalled about 65,885 DDU-100 series semi-automatic external defibrillators (AEDs) sold in the United States under the brand names Lifeline AED and ReviveR AED. These recalled defibrillators may, in rare cases, cancel shock while charging, which could cause a failure to resuscitate the patient.

Next Page »