FDA MedWatch Alerts

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S.W.A.G: Public Notification - Undeclared Drug Ingredient

April 18, 2014

Audience: Consumer. [Posted 04/18/2014] ISSUE: FDA is advising consumers not to purchase or use S.W.A.G, a product promoted and sold for sexual enhancement. FDA laboratory analysis confirmed that S.W.A.G contains sildenafil, the active ingredient in the FDA approved prescription drug Viagra, used to treat erectile dysfunction (ED). This undeclared ingredient may interact with nitrates found in some prescription...

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Propofol Injectable Emulsion, USP by Hospira: Recall - Visible Particulates

April 18, 2014

Audience: Risk Manager, Pharmacy, Anesthesiology. ISSUE: Hospira notified the public of a nationwide recall of seven lots of Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL) to the user level due to a glass defect located on the interior neck of the vial. The defect was identified during a sample inspection where the glass vial contained visible embedded metal particulate. Free-floating metal particulates...

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Thinogenics Products by Nature’s Universe: Recall - Undeclared Drug Ingredient

April 18, 2014

Audience: Consumer. [Posted 04/18/2014] ISSUE: Nature’s Universe notified the public it is recalling all lots of Thinogenics product sold prior to February 6, 2014 to the user level after FDA analysis revealed that the affected product contained undeclared sibutramine. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010, due to increased risk of seizures, heart...

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Laparoscopic Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication - Use Discouraged Due to Increased Risk in Women With Uterine Fibroids

April 17, 2014

Audience: Internal Medicine, Nursing, OB/GYN, Oncology. [Posted 04/17/2014] ISSUE: FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids. It is estimated that 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma. If...

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FreeStyle and FreeStyle Flash Blood Glucose Meter by Abbott: Recall - May Produce Mistakenly Low Blood Glucose Results

April 14, 2014

Audience: Consumer, Pharmacy. including the OmniPod Insulin Management System with the built-in FreeStyle Blood Glucose Meter   UPDATED 04/14/2014. FDA classified this product recall as Class I.   [Posted 03/16/2014] ISSUE: Abbott is conducting a recall for the FreeStyle Blood Glucose Meter and the FreeStyle Flash Blood Glucose Meter. When used with the Abbott FreeStyle test strips, the FreeStyle Blood...

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Lite Fit USA: Public Notification - Undeclared Drug Ingredient

April 11, 2014

Audience: Consumer. [Posted 04/11/2014] ISSUE: FDA is advising consumers not to purchase or use Lite Fit USA. FDA laboratory analysis confirmed that Lite Fit USA contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse...

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Infinity: Public Notification - Undeclared Drug Ingredient

April 11, 2014

Audience: Consumer. [Posted 04/11/2014] ISSUE: FDA is advising consumers not to purchase or use Infinity. FDA laboratory analysis confirmed that Infinity contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in...

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Zi Xiu Tang Bee Pollen Capsules by Guangzhou Zi Xiu Tang Biotechnology Co., Ltd: Warning - Undeclared Drug Ingredients

April 8, 2014

Audience: Consumer. ISSUE: FDA has tested multiple Zi Xiu Tang Bee Pollen products from various distributors in the United States (US). All products that have been tested, including those that claim to be “genuine” and “anti-counterfeit,” have been found to contain one or both of the undeclared drug ingredients sibutramine and Phenolphthalein. FDA has received dozens of adverse event reports, including many...

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Nova Products, Inc. Dietary Supplements: Recall - Undeclared Drug Ingredients

March 31, 2014

Audience: Consumer. Including African Black Ant, Black Ant, XZen Gold, ZXen Platinum, XZen 1200, XZone Gold, and XZone 1200 [Posted 03/31/2014] ISSUE: Nova Products, Inc. issued a voluntary recall of the following products: African Black Ant (Lot# 2006-000926), Black Ant (Lot# 2006-3627878), XZen Gold (Lot# 130310GL), ZXen Platinum (Lot# 130520PL), XZen 1200 (Lot# 13051012), XZone Gold (Lot# 131110GL), and XZone...

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Revatio (sildenafil): Drug Safety Communication - FDA Clarifies Warning About Pediatric Use for Pulmonary Arterial Hypertension

March 31, 2014

Audience: Cardiology, Pediatrics, Pharmacy. ISSUE: FDA is clarifying its previous recommendation related to prescribing Revatio (sildenafil) for children with pulmonary arterial hypertension (PAH). Revatio is FDA-approved only to treat PAH in adults, not in children; however, health care professionals must consider whether the benefits of treatment with the drug are likely to outweigh its potential risks for each...

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Alli (60 mg orlistat capsules) by GlaxoSmithKline: Recall - Product Tampering

March 28, 2014

Audience: Consumer. ISSUE:  GlaxoSmithKline (GSK) Consumer Healthcare is voluntarily recalling all alli weight loss products from U.S. and Puerto Rico retailers as the company believes that some packages of the product were tampered with and may contain product that is not authentic Alli. GSK received inquiries from consumers in seven states about bottles of alli that contained tablets and capsules that were not...

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New Life Nutritional Center Dietary Supplements: Recall - Undeclared Drug Ingredients

March 26, 2014

Audience: Consumer. Including Super Fat Burner Capsules, Maxi Gold Capsules, and Esmeralda Softgels [Posted 03/26/2014] ISSUE: New Life Nutritional Center is recalling all lots of “Super Fat Burner capsules, Maxi Gold capsules and Esmeralda softgels” to the user level after FDA analysis revealed the products contain undeclared active pharmaceutical ingredients: sibutramine, phenolphthalein or a combination of...

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Bella Vi Brand Products by Pure Edge Nutrition: Recall - Undeclared Drug Ingredients

March 26, 2014

Audience: Consumer. Including Bella Vi Insane Bee Pollen Capsules, Bella Vi BTrim Ultimate Boost, Bella Vi BTrim Max, Bella Vi Extreme Accelerator, Bella Vi Insane Amp’d, and Bella Vi Amp’d Up [Posted 03/26/2014] ISSUE: Pure Edge Nutrition, LLC is voluntarily recalling one lot of each: Bella Vi Insane Bee Pollen Capsules, Bella Vi BTrim Ultimate Boost, Bella Vi BTrim Max, Bella Vi Extreme Accelerator, Bella Vi...

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Pleo Homeopathic Drug Products by Terra-Medica: Recall - Potential for Undeclared Penicillin

March 20, 2014

Audience: Consumer. Includes Pleo-FORT, Pleo-QUENT, Pleo-NOT, Pleo-STOLO, Pleo-NOTA-QUENT, and Pleo-EX [Posted 03/20/2014] ISSUE: Terra-Medica, Inc. is voluntarily recalling 56 lots of Pleo-FORT, Pleo-QUENT, Pleo-NOT, Pleo-STOLO, Pleo-NOTA-QUENT, and Pleo-EX homeopathic drug products in liquid, tablet, capsule, ointment, and suppository forms to the consumer level. FDA has determined that these products have...

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Vitaccino Coffee: Public Notification - Undeclared Drug Ingredient

March 19, 2014

Audience: Consumer. [Posted 03/19/2014] ISSUE: FDA is advising consumers not to purchase or use Vitaccino Coffee, a product promoted and sold for weight loss. FDA laboratory analysis confirmed that Vitaccino Coffee contains sibutramine, a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers, because sibutramine is known to substantially...

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FreeStyle and FreeStyle Flash Blood Glucose Meter by Abbott: Recall - May Produce Mistakenly Low Blood Glucose Results

March 16, 2014

Audience: Consumer, Pharmacy. including the OmniPod Insulin Management System with the built-in FreeStyle Blood Glucose Meter   [Posted 03/16/2014] ISSUE: Abbott is conducting a recall for the FreeStyle Blood Glucose Meter and the FreeStyle Flash Blood Glucose Meter. When used with the Abbott FreeStyle test strips, the FreeStyle Blood Glucose Meter and the FreeStyle Flash Blood Glucose Meter may produce...

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Merit Medical Systems, Custom Procedural Trays/Kits Containing 1 percent Lidocaine HCl Injection, USP, 10mg/mL: Recall - Particulates Found in Hospira supplied Lidocaine

March 14, 2014

Audience: Risk Manager. [Posted 03/14/2014] ISSUE: Hospira, Inc. is recalling one lot (# 25-090-DK) of 1% Lidocaine HCl Injection which is contained in the Merit Medical Systems Custom Procedural Trays/Kits. These trays/kits were recalled due to one confirmed customer report of visible particulate, identified in the primary product container, in the form of dark red/black particles. The particulate was identified...

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Reumofan Plus: Recall - Undeclared Drug Ingredient

March 14, 2014

Audience: Consumer. [UPDATED 03/14/2014] Pain Free By Nature is recalling "Reumofan Plus" Tablets purchased through their website at www.painfreebynature.com, after FDA discovered that the product was distributed in packaging that did not reveal the presence of the active pharmaceutical ingredients methocarbamol and diclofenac, making it an unapproved drug. Use of this product could result in serious and...

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VPRIV (velaglucerase alfa for injection): Recall - Visible Particulate Matter

March 14, 2014

Audience: Risk Manager, Pharmacy. ISSUE: Shire Pharmaceuticals announced a voluntary recall in the United States of one batch, packaged into three lots, of VPRIV due to the presence of visible particulate matter, identified as stainless steel and barium sulfate. The particulate matter was found in a small number of vials in the three packaged lots of VPRIV. A Shire investigation identified the particulate matter...

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Effexor XR 150 Mg Extended-Release Capsules (Pfizer) and Venlafaxine HCl 150 Mg Extended-Release Capsules (Greenstone): Recall - Possible Presence of Tikosyn Capsules

March 7, 2014

Audience: Pharmacy, Psychiatry, Family Practice. [Posted 03/07/2014] ISSUE:  Pfizer Inc. issued a voluntary recall of one lot of 30-count Effexor XR (venlafaxine HCl) 150 mg extended-release capsules, one lot of 90-count Effexor XR (venlafaxine HCl) 150 mg extended-release capsules, and one lot of 90-count Greenstone LLC-branded Venlafaxine HC1 150 mg extended-release capsules. This action is being taken because...

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