There have been no reports of patient injury or death associated with the product.

An arterial cannula is a disposable tube inserted in the aorta during many cardiac bypass surgery procedures and is used to perfuse the ascending aorta. The cannula is inserted using an introducer, which stabilizes the cannula during insertion and is then removed.

Terumo CVS distributed this product directly to 68 U.S. hospitals, and has notified all of the hospitals of the voluntary recall in a letter dated Oct. 16, 2008. The product was also distributed from distribution centers in Australia, Canada and Europe. The notification letter recommended that customers not use the product unless medically necessary. In those cases, the cannula should be used without the introducer. Clinicians with questions may contact the company at 800-521-2818, or if calling from outside the U.S., 734-663-4145. Contact can be made Monday-Friday from 8:00 a.m. to 5:00 p.m. EST.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: 1-800-FDA-0178

Terumo informed the U.S. Food and Drug Administration of this recall. Terumo Cardiovascular Systems Corporation is a global manufacturer and marketer of medical devices for cardiac and vascular surgery. The company is headquartered in Ann Arbor, Michigan with manufacturing operations in Ann Arbor; Elkton, Maryland; Ashland, Massachusetts; and Tustin, California. For more information, visit www.terumo-cvs.com.

Source: FDA

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The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA’s request by U.S. Marshals. These products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin’s anticoagulant activity.

“This action will help prevent this contaminated heparin from finding its way into the marketplace,” said Mike Chappell, acting associate commissioner for regulatory affairs, FDA.

Heparin is a blood-thinning drug. An API is a substance or mixture of substances that, when delivered in a finished drug product, directly affects the structure or function of the body. Heparin Sodium USP is an API that may be incorporated into finished drug products. Heparin Lithium is used in certain medical devices including vacutainer blood collection tubes, some in vitro diagnostic assays, and as a coating for capillary tubes. Celsus has distributed Heparin Sodium USP and Heparin Lithium to manufacturers in both the United States and abroad.

OSCS contaminant in injectable drug products containing heparin has been linked to multiple adverse events and deaths initially reported to the FDA in January 2008. Since then, the FDA has put in place a comprehensive inspection and import controls program and has acted to remove from the market heparin materials and products contaminated with OSCS. The seized Celsus heparin – which had entered the United States before the establishment of import controls for the drug – was tested for the presence of OSCS as part of this FDA effort.

To date, the agency has initiated 13 recalls of multiple contaminated medical products containing heparin from several companies.

The FDA informed Celsus Laboratories during an April 2008 inspection and again in a May 8, 2008, letter that the company’s actions to notify customers about a contaminant in its heparin were insufficient to assure an effective recall. The agency advises manufacturers who may have purchased heparin from Celsus to contact the company to make certain they are not using any heparin from the seized lots because the product does not meet acceptable quality standards.

The FDA has notified Japanese, Canadian, Australian, European Union, and other international authorities of shipments of contaminated heparin from Celsus.

Source: FDA

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Jack Distribution, LLC, is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Rize 2 and Rose 4 Her samples of random lots found the product contains potentially harmful, undeclared ingredients. FDA asserts that its chemical analysis revealed that Rize 2 The Occasion and Rose 4 Her contain thiomethisosildenafil, an analog of sildenafil, the active ingredient of a FDA-approved drug used for Erectile Dysfunction (ED). FDA maintains that this ingredient is close in structure to sildenafil and is expected to possess a similar pharmacological and adverse event profile. This undeclared chemical poses a potential threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.

Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.

Any adverse events that may be related to the use of this product should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

The company advises that any unused portions can be returned to the place of purchase for a full refund of purchase price. Jack Distribution will manufacture new lots of these products which are not subject to the recall. Those lot numbers will begin with “BL” and will begin to be sold shortly.

Rize 2 and Rose 4 Her are sold in adult stores, vitamin & nutrition shops, convenience stores, and via the internet nationwide. The Rize 2 product is sold as a (single blister pack, three count bottles, twelve count bottles, and thirty count bottles. Rose 4 Her is only available in single blister packs and three count bottles.

The Company is taking this voluntary action because it is committed and is always concerned with the health of persons who have consumed this product. The Company is reviewing the procedures and policies of all firms involved with the manufacture of the product to ensure that there will be no future issues with regard to Rize 2 and Rose 4 Her pills composition. The Company is working closely with the FDA in the recall process and is committed to the quality and integrity of its products. It sincerely regrets any inconvenience to consumers and its other customers.

Source: FDA

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Today’s action follows a formal FDA request to SEI Pharmaceuticals (SEI) on May 27, 2008, to recall the lots of Xiadafil VIP tablets. The products were given away at trade shows and sold in eight tablet bottles (Lot # 6K029) and blister cards of two tablets (Lot # 6K029-SEI) bearing an expiration date of September 2009 (09/09). The company, however, refused to recall these products, making the seizure action necessary to prevent additional, illegal Xiadafil VIP products from entering the marketplace.

The FDA’s chemical analysis of Xiadafil VIP tablets Lots # 6K029/6K029-SEI found that the product contains hydroxyhomosildenafil, which is chemically similar to sildenafil. Sildenafil is the active ingredient in Viagra, an FDA-approved prescription drug for ED. The FDA has not approved Xiadafil VIP for ED or any other drug use, and the safety and effectiveness of this product is unknown. Although offered for sale as dietary supplements, the seized articles are new drugs that may not be introduced into interstate commerce without an approved new drug application filed with FDA.

“Today’s seizure action shows that FDA will take enforcement action to protect the public from dietary supplements that contain prescription drug ingredients that are potentially harmful to consumers,” said Margaret O’K Glavin, associate commissioner of the FDA’s Office of Regulatory Affairs. “FDA will not tolerate a company’s failure to take voluntary action to protect the public health after being given the opportunity by FDA to do so,” she added.

On April 22, 2008, the FDA initiated an inspection at SEI Pharmaceuticals following its analysis of the Xiadafil VIP tablets. The company was advised of the FDA’s findings and informed of the potential adverse health risks the product posed to unsuspecting consumers. The FDA also warned the company of possible legal actions, including seizure and/or injunction if corrective and preventive actions were not implemented. Although the company committed to halting distribution of the product and deactivated its Internet site, it refused to recall the product already in the market.

On May 13, 2008, Florida state officials issued a “stop sale” action at SEI’s distribution facility to keep the illegal product out of the marketplace. This action required SEI to hold, intact, violative Xiadafil VIP tablets found at the facility.

ED is a common problem in men who have diabetes, high blood pressure, high cholesterol, or heart disease. Because they may have been advised against taking ED drugs, men with these conditions may seek alternative products like Xiadafil VIP tablets because they are marketed as “all natural” or as not containing the active ingredients in approved, prescribed ED drugs. Furthermore, because the manufacturing source of the active ingredients in many of these alternative products is unknown, consumers should also be aware that the safety, efficacy, and purity of these ingredients have not been verified by the FDA.

Consumers should discontinue the use of Xiadafil VIP tablets immediately and consult their health care professional if they have experienced adverse events that they believe may be related to the use of this product.

Consumers and health care professionals can report adverse events to the FDA’s MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Md 20852-9787, or online at www.fda.gov/medwatch/report.htm.

Source: FDA

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Roxane Laboratories’ number one priority is for the safety of patients who use our products. A sample from product lot 856396A tested positive for a strain of yeast, which could potentially affect immunocompromised patients. Roxane Laboratories believes that this may be attributed to yeast contamination in one lot of high-density polyethylene bottles received from a supplier. There are various manifestations of yeast infections. The risk of developing a yeast infection depends on how immunocompromised the patient is. Additionally, there are a range of symptoms in a yeast infection from thrush, skin rash, and blood infections (sepsis). If patients develop an infection they should consult their physician. Due to the potential risks that could occur in immunocompromised patients, Roxane Laboratories is voluntarily recalling lot 856396A. Although there have been no testing failures associated with lot 856693A, this additional lot is also being included in the recall as a precautionary measure because the same lot of bottles was used in both finished product lots. All other product parameters were within specification and product efficacy is not impacted. There have been no complaints or adverse events reported for the affected lots. This recall is limited to the two lot numbers listed. No other Roxane Laboratories, Inc. products or lots are impacted by this recall.

Information has been sent to Pharmacists alerting them of the details pertaining to this recall. As described in these recall communications, pharmacists who may have dispensed Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles from Lots 856396A and 856693A are instructed to contact those patients to return the affected product to the pharmacist.

Pharmacists and wholesalers that have any Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles from Lot 856396A or Lot 856693A have been instructed to discontinue distribution and use of these lots immediately and contact Capital Returns at 888.839.7837 for any questions regarding the recall returns. Requests for additional information should be referred to Roxane Laboratories Technical Product Information at 800.962.8364.

Advice For Patients Taking Sodium Polystyrene Sulfonate Suspension USP, 15 g/60 Ml Unit Dose Bottles

If your pharmacist has notified you that you may have received a bottle from one of the lots listed in this recall, please return your Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles to your pharmacist.

If you have NOT been notified by your pharmacist, please check your product to determine if it is from either of the two affected lots: Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles from Lot 856396A Exp April 2010, or Lot 856693A Exp May 2010. If the product has either of these two lot numbers on the bottle, please contact your pharmacist for further instructions. This recall has been limited to these two specific lots.

Roxane Laboratories is working with the US FDA on this voluntary recall. The products discussed in this press release are available by prescription only, and no injuries have been reported in relation to this issue.

Source: FDA

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Jack Distribution, LLC, is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Rize 2 and Rose 4 Her samples from lots manufactured and packaged in 2007 found the product contains potentially harmful, undeclared ingredients. FDA asserts that its chemical analysis revealed that these lots of Rize 2 The Occasion and Rose 4 Her contain thiomethisosildenafil, an analog of sildenafil, the active ingredient of a FDA-approved drug used for Erectile Dysfunction (ED). FDA maintains that this ingredient is close in structure to sildenafil and is expected to possess a similar pharmacological and adverse event profile. This undeclared chemical poses a potential threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.

Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.

Any adverse events that may be related to the use of this product should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

The company advises that any unused portions from these lot numbers be returned to the place of purchase for a full refund of purchase price. G & N Works and Devine Distribution are not shipping any Rize 2 or Rose 4 Her that is in stock while additional samples are being tested, they expect to begin shipping again in 2-4 weeks.

Rize 2 and Rose 4 Her are sold in adult stores, vitamin & nutrition shops, convenience stores, and via the internet nationwide. The Rize 2 product is sold as a (single blister pack, three count bottles, twelve count bottles, and thirty count bottles. Rose 4 Her is only available in single blister packs and three count bottles.

The Company is taking this voluntary action because it is committed and is always concerned with the health of persons who have consumed this product. The Company is reviewing the procedures and policies of all firms involved with the manufacture of the product to ensure that there will be no future issues with regard to Rize 2 and Rose 4 Her pills composition. The Company is working closely with the FDA in the recall process and is committed to the quality and integrity of its products. It sincerely regrets any inconvenience to consumers and its other customers.

Source: FDA

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B. cepacia poses little medical risk to healthy people. However, people who have certain health problems such as weakened immune systems or chronic lung diseases, particularly cystic fibrosis (CF), may be more susceptible to infections with B. cepacia. B cepacia is a known cause of infections in hospitalized patients. The effects of B. cepacia on people vary widely, ranging from no symptoms at all, to serious respiratory infections, especially in patients with CF. The intended application of the 2% CHG Cloth product is topical, for the skin only, and it is not for oral or internal use.
The recall includes the following products:

Product was distributed to U.S. hospitals and medical centers nationwide. Affected product was shipped between 4/28/08 and 6/19/08. This voluntary recall is being conducted with the knowledge of the Food and Drug Administration. Sage Products has received no reports of patient injury. No other products from Sage are included in this recall.

Customers who have these products should stop usage, sale and distribution, and should contact Sage Products to coordinate product return and replacement. Additional information is posted at www.sageproducts.com/recall.

Sage Products Customer Service hotline: 1-800-421-6556.

Return unused product to:
Sage Products Inc.
C/O Customer Service Department
3909 Three Oaks Road, Cary, IL 60013

Source: FDA

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Oversized tablets may contain as much as two times the labeled level of active morphine sulfate.  The recalled lots were distributed by ETHEX Corporation under an “ETHEX” label between June 2006 and May 2008.  The lot numbers involved in the recall are:

Morphine Sulfate ER 30mg Tablet/NDC # 58177-320-04:  Lots 75090, 77846, 77847, 80048, 83320, 89661, 89665, 90252 through 90258, and 93284

Morphine Sulfate ER 60mg Tablet/NDC # 58177-330-04:  Lots 91762 (previously reported), 75091, 75092, 77848 through 77851, 82517, 82518, 83333, 83817, 83862, 84111, 84112, 84315, 84900, 85326, 85335, 85807, 86270 through 86276, 87723, 87939, 88007, 89083, 89668, 89669, 89821, 90260 through 90272, and 91763 through 91765.

No report of unexpected side effects or injury has been received.  However, opioids such as morphine, have life-threatening consequences if overdosed.  Those consequences can include respiratory depression (difficulty or lack of breathing), and low blood pressure, apnea, and hypotension.

The voluntary recall follows a report that a tablet with as much as double the appropriate thickness was identified in a previously recalled lot.  No oversized tablets have been identified in any additional distributed lot of these products and, based on our investigation, there are likely to be few, if any, oversized tablets in the recalled lots.  The decision to recall the additional lots listed above has been taken as a responsible precaution because of the possibility that there may be oversized tablets in those lots.

The 60 mg product is a white oval tablet with “60” on one side, and “E” on the reverse.  The 30 mg product is a pink oval tablet with “30” on one side, and “E” on the reverse.

Any customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-321-1705, or fax to ETHEX Customer Service at 314-646-3751 or sent via email to: customer-service@ethex.com with representatives available Monday through Friday, 8 am to 5 pm CDT.

ETHEX Corporation has initiated recall notifications to wholesalers and retailers who have received any inventory of the recalled lots of this product with instructions for returning the recalled product and, if they have not already done so, they are urged to contact the number above regarding procedures for returning the recalled product.  If consumers have any questions about the recall, they should call the number above, their physician, their pharmacist or other health care provider.

This recall is being conducted with the knowledge of the Food and Drug Administration (FDA).
Any adverse reactions experienced with the use of this product, and/or quality problems may also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Source: FDA

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The voluntary single-lot recall is due to a report that a tablet with as much as double the appropriate thickness was identified and the possibility therefore that there may be other similar oversized tablets that may have been commercially released in the affected lot. Such tablets may contain as much as twice the labeled level of active morphine ingredient. The product is a white oval tablet with “60″ on one side, and “E” on the reverse.

No report of unexpected side effects or injury has been received. However, opioids such as morphine have life-threatening consequences if overdosed. Those consequences can include respiratory depression (difficulty or lack of breathing), and low blood pressure. Many patients for whom this product is prescribed are likely to be highly debilitated with reduced strength or energy as a result of illness. As such, they may be less likely to be able to determine that a tablet is overweight or oversized than an unimpaired individual.

Any customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-321-1705, or fax to ETHEX Customer Service at 314-646-3751 or sent via email to: customer-service@ethex.com with representatives available Monday through Friday, 8 am to 5 pm CST.

ETHEX Corporation previously initiated the recall notification to wholesalers and retailers who have received any inventory of the recalled lot of this product with instructions for returning the recalled product and, if they have not already done so, they are urged to contact the number above regarding procedures for returning the recalled product. If consumers have any questions about the recall, they should call the number above, their physician, their pharmacist or other health care provider.

This recall is being conducted with the knowledge of the Food and Drug Administration (FDA).
Any adverse reactions experienced with the use of this product, and/or quality problems may also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Source: FDA

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International Pharmaceuticals, Ltd. is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of a sample from one lot of the product revealed that it contained a potentially harmful undeclared ingredient, hydroxyhomosildenafil.  FDA asserts that this ingredient is an analog of sildenafil.  Sildenafil is the active chemical ingredient of an FDA-approved drug used for Erectile Dysfunction (ED) in men to enhance sexual performance. The use of undeclared chemicals pose a threat to consumers because they may harmfully interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.  Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take such nitrates.

VIP Tabs are sold in retail outlets nationwide and are packaged into 2-capsule blister packs and 8-capsule bottles.

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.

The Company advises that any unused portions be returned to CB Distributors in Benoit, Wisconsin, in accordance with return instructions/questions obtained by calling (800)-273-4137, Ext. 3.

Any adverse events that may be related to the use of this product should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online at www.fda.gov/medwatch/report.htm.

The Company is working closely with the FDA in the recall process and is taking this voluntary action because it is committed to the quality and integrity of it’s products, and is always concerned with the health of persons who may have consumed this product.

The Company sincerely regrets any inconvenience to consumers, and is reviewing the procedures and policies of all firms involved with the manufacture of this product to ensure that there will be no subsequent issues with regard to the composition of this product in the future.

Source: FDA

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