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Recalls and Alerts
Click here for all 2008 Recalls and Alerts.
Click here for all 2007 Recalls and Alerts.
Click here for all 2006 Recalls and Alerts.
Click here for all 2005 Recalls and Alerts.
Click here for all 2004 Recalls and Alerts.
Click here for all 2003 Recalls and Alerts.
5/6/2008
Cardinal Health Alcohol-Free Mouthwash Recalled
A recall has been issued for Cardinal Health alcohol-free mouthwash (Hydrox Labs) because the product was found to be contaminated with Burkholderia cepacia. The recall affects 4-oz bottles with the lot number 26228. The product was distributed to hospitals, medical centers, and long-term care facilities throughout the United States and was also included in personal hygiene hospital admission kits. Normally, B Cepacia poses minimal risk to healthy individuals; however, patients who are immunocompromised may be more susceptible to infection.
Consumers and institutions who have purchased the recalled product should stop using the product and should call Cardinal Health at (800) 292-9332 for instructions on returning the product.
More information is available at
FDA MedWatch.
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5/1/2008
Etanercept Labeling Revised with Warning for Serious Infections
Prescribing information for etanercept (Enbrel) has been revised to include a boxed warning that describes the risk of serious infections that may require hospitalization or result in death. These infections include bacterial sepsis and tuberculosis. The adverse reactions section has also been updated to include information and global clinical studies that describe the occurrence rate of tuberculosis in patients treated with etanercept.
Warning patients about symptoms of infection is important. Close follow-up for signs and symptoms of infection is essential during and after treatment with etanercept. If serious infection occurs while taking etanercept, the drug should be discontinued.
More information is available at
FDA MedWatch.
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4/28/2008
Class I Recall Issued for Digoxin (Digitek)
A class I recall has been issued for digoxin (Digitek) distributed by Mylan Pharmaceuticals under a Bertek label and by UDL Laboratories under a UDL label. All strengths of Digitek are affected by the recall. The product recall was prompted because of the potential for the tablets to be double the appropriate thickness. The tablets may also contain twice the amount of the active ingredient.
Double-strength tablets increase the risk of digitalis toxicity, particularly in patients with renal insufficiency. Digitalis toxicity causes nausea, vomiting, dizziness, hypotension, arrhythmia, and bradycardia. Several reports have noted toxicity with the recalled tablets. Patients should contact their physician to obtain another digoxin product.
More information is available at
FDA MedWatch.
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4/14/2008
Twelve Dietary Supplements Recalled From Herbal Science International Inc
A nationwide recall has been issued for 12 dietary supplements containing ephedra, aristolochic acid, or human placenta from Herbal Science International. Since 2004, the US Food and Drug Administration (FDA) has banned the sale of ephedra, a botanical substance that contains ephedrine alkaloids, because of it potential to dangerously elevate blood pressure. Ephedrine has been associated with myocardial infarctions and stroke.
Several of the products affected by the recall contain aristolochic acid, a potent carcinogen and nephrotoxin, which has been associated with reports of kidney failure. A product containing human placenta is also recalled and may transmit disease. Dietary supplements that contain human placenta are not lawfully sold in the United States.
Products recalled that contain ephedra
- Wu Yao Shun Qi San
- Qing Bi Tang (Nasal Cleanser)
- Zhong Fong Huo Luo Wan (Stroke Revito Formula)
- Xiao Qing Long Tang (Little Green Dragon)
- Ding Chuan Tang
- Xiao Xu Ming Tang
- Feng Shi Zhi Tong Wan (Joint Relief)
- Guo Min Bi Yan Wan
- Fan Feng Tong Sheng San
Products recalled that contain aristolochic acid
- Tou Tong San (Headache Formula)
- Du Huo Ji Sheng Tang (Du Huo Joint Relief)
Product recalled that contains human placenta
At this time, no injuries or illnesses have been reported with the specific recalled products and sale of the products has stopped. Consumers are advised to immediately discontinue use of the affected products and return the products to their place of purchase.
More information is available at
FDA MedWatch.
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4/11/2008
Rabbit Antithymocyte Globulin (Thymoglobulin) Recalled
A recall has been issued for rabbit antithymocyte globulin (Thymoglobulin; Genzyme). The recall was prompted when one lot failed a periodic stability test (ie, lot number C7014C01 [expiration May 31, 2010]). Two additional lots were also recalled based on predicted stability failure and include lot numbers C7008C01 (expiration March 31, 2010) and TH175-05 (expiration October 4, 2009). Use of the affected lots should be discontinued immediately and vials should be returned to Genzyme Corporation.
More information is available at
FDA MedWatch.
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4/10/2008
Progressive Multifocal Leukoencephalopathy (PML) and Mycophenolate
The US Food and Drug Administration (FDA) is investigating a potential association between progressive multifocal leukoencephalopathy (PML) and the use of mycophenolate (CellCept, Myfortic). Mycophenolate is indicated to prevent organ rejection following solid organ transplantation. PML is a rare, life-threatening disease that affects the CNS and may occur in patients with immune systems suppressed by disease or medications. For further information, see the second link provided below.
Until further information is available, patients and health care professionals should be aware of possible PML development associated with mycophenolate use. Symptoms that indicate progressive focal neurologic deficit associated with PML include limb weakness, weakness and disturbance of speech, cognitive abnormalities, headaches, gait disorders, visual impairment, and sensory loss.
More information is available at
FDA MedWatch.
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