http://www.drugs.com/fda_alerts.html FDA MedWatch Alerts from Drugs.com. Comprehensive and up-to-date drug news for both consumers and healthcare professionals. en http://www.drugs.com/fda/clinical-specialties-compounding-pharmacy-products-recall-all-sterile-products-recalled-due-lack-13260.html Audience: Health Professional, Pharmacy, Patient ISSUE: Clinical Specialties is voluntarily recalling all lots of all sterile products repackaged and distributed by the pharmacy due to lack of sterility assurance. The recall of all sterile products... Thu, 21 Mar 2013 04:00:00 GMT http://www.drugs.com/fda/avastin-unit-syringes-clinical-specialties-recall-potential-serious-eye-infection-13259.html Audience: Eye Care, Health Professional, Patient ISSUE: Clinical Specialties is voluntarily recalling Avastin unit dose syringes. The product has or potentially could result in an infection within the eye. Clinical Specialties has received reports... Wed, 20 Mar 2013 04:00:00 GMT http://www.drugs.com/fda/med-prep-consulting-inc-compounded-products-recall-potential-mold-contamination-13257.html Audience: Risk Manager, Pharmacy, Family Practice ISSUE: Med Prep Consulting, Inc. notified the public that it is recalling all lots of all products compounded at its facility, due to lack of sterility assurance. The level of recall is to the user:... Mon, 18 Mar 2013 04:00:00 GMT http://www.drugs.com/fda/incretin-mimetic-type-2-diabetes-early-communication-reports-possible-increased-risk-pancreatitis-13255.html Audience: Gastroenterology, Endocrinology, Oncology, Patient ISSUE: FDA is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis and pre-cancerous cellular changes called pancreatic... Thu, 14 Mar 2013 04:00:00 GMT http://www.drugs.com/fda/night-bullet-recall-undeclared-ingredient-13254.html Audience: Consumer ISSUE: Green Planet, Inc. notified the public of a recall of its dietary supplement product Night Bullet. Analytical tests conducted by the FDA found that the product contains trace amounts of Sulfohydroxyhomosildenafil and... Tue, 12 Mar 2013 04:00:00 GMT http://www.drugs.com/fda/azithromycin-zithromax-zmax-safety-communication-risk-potentially-fatal-heart-rhythms-13253.html Audience: Family Practice, Patient, Pharmacy, Health Professional ISSUE: FDA is warning the public that azithromycin (Zithromax or Zmax) can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal... Tue, 12 Mar 2013 04:00:00 GMT http://www.drugs.com/fda/sensipar-cinacalcet-hydrochloride-safety-communication-fda-suspends-pediatric-clinical-trials-after-13251.html Audience: Health Professional, Endocrinology, Pediatrics ISSUE: FDA has stopped all pediatric clinical trials of Sensipar (cinacalcet hydrochloride) after the recent death of a 14-year-old patient in a trial.  Posting this information does not mean... Tue, 26 Feb 2013 05:00:00 GMT http://www.drugs.com/fda/maxiloss-weight-advanced-softgels-recall-undeclared-ingredient-13250.html Audience: Consumer ISSUE: Olaax Corp announced a nationwide recall of the company's dietary supplement sold under the brand name Maxiloss Weight Advanced Softgels to the user level, because FDA testing found the Maxiloss Weight Advanced product to... Mon, 25 Feb 2013 05:00:00 GMT http://www.drugs.com/fda/omontys-peginesatide-affymax-takeda-recall-all-lots-serious-hypersensitivity-reactions-13248.html Audience: Patients, Healthcare Professionals, Nephrology, Hematology ISSUE: Affymax, Inc. and Takeda Pharmaceutical Company Limited along with the U.S. Food and Drug Administration (FDA) are informing the public of a voluntary recall of all lots of... Sat, 23 Feb 2013 05:00:00 GMT http://www.drugs.com/fda/codeine-certain-children-after-tonsillectomy-adenoidectomy-safety-communication-risk-rare-but-13245.html Audience: Pediatricians, Surgery, Consumer [UPDATED 02/20/2013] FDA notified the public about new actions being taken to address a known safety concern with codeine use in certain children after tonsillectomy and/or adenoidectomy (surgery to... Wed, 20 Feb 2013 05:00:00 GMT http://www.drugs.com/fda/reumofan-plus-recall-undeclared-ingredient-13246.html Audience: Consumer, Health Professional, Emergency Medicine Reumofan Plus USA, LLC and Reumofan USA, LLC is recalling "Reumofan Plus" Tablets, Lot# 99515, exp. 09/16, because they contain undeclared active pharmaceutical ingredients: methocarbamol,... Tue, 19 Feb 2013 05:00:00 GMT http://www.drugs.com/fda/vistide-cidofovir-gilead-recall-presence-particulate-matter-13244.html Audience: Pharmacy, Patient, Health Professional ISSUE: Gilead Sciences, Inc. is voluntarily recalling lot B120217A of Vistide® (cidofovir injection) to the user level due to the presence of  particulate matter found in some vials of this... Sat, 16 Feb 2013 05:00:00 GMT http://www.drugs.com/fda/lactated-ringers-5-percent-dextrose-usp-1000-ml-flexible-containers-recall-due-non-sterility-13237.html Audience: Pharmacy, Patient, Health Professional ISSUE: Hospira, Inc. is initiating a voluntary nationwide user-level recall of one lot of Lactated Ringers and 5% Dextrose Injection, USP, 1000 mL, Flexible Container, NDC 0409-7929-09. This action is... Mon, 28 Jan 2013 05:00:00 GMT http://www.drugs.com/fda/samsca-tolvaptan-warning-potential-risk-liver-injury-13236.html Audience: Gastroenterology, Nephrology, Pharmacy ISSUE: Otsuka and FDA notified healthcare professionals of significant liver injury associated with the use of Samsca. In a double-blind, 3-year, placebo-controlled trial in about 1400 patients with... Fri, 25 Jan 2013 05:00:00 GMT http://www.drugs.com/fda/ferrous-sulfate-325-mg-labeled-rugby-natural-iron-supplement-recall-bottle-may-contain-meclizine-13234.html Audience: Pharmacy, Consumer ISSUE: Advance Pharmaceutical Inc. notified the public of a recall of one lot of Ferrous Sulfate Tablets 325 mg, after notification by a pharmacist that a bottle of Ferrous Sulfate Tablets, 325 mg contained Meclizine... Fri, 18 Jan 2013 05:00:00 GMT http://www.drugs.com/fda/mobius-brand-mitosol-mitomycin-solution-kit-ophthalmic-recall-may-not-sterile-13232.html Audience: Ophthalmology ISSUE: Mobius Therapeutics announced that it is conducting a voluntary recall of 2 lots of Mitosol (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use. The company cannot exclude the possibility that the affected... Thu, 10 Jan 2013 05:00:00 GMT http://www.drugs.com/fda/zolpidem-containing-products-safety-communication-fda-requires-lower-recommended-doses-13231.html Audience: Family Practice, Health Professional, Patient Including Ambien, Ambien CR, Edluar, and Zolpimist    [Posted 01/10/2013] ISSUE: FDA is notifying the public of new information about zolpidem, a widely prescribed insomnia drug. FDA... Thu, 10 Jan 2013 05:00:00 GMT http://www.drugs.com/fda/slimdia-revolution-public-notification-contains-undeclared-ingredient-sibutramine-13224.html Audience: Consumer UPDATED 12/21/2012  P&J Trading announced today that it is conducting a voluntary nationwide recall of the company's dietary supplements sold under the brand name SLIMDIA REVOLUTION after being notified by FDA that testing found... Fri, 21 Dec 2012 05:00:00 GMT http://www.drugs.com/fda/hydrocodone-bitartrate-acetaminophen-10-mg-500-mg-recall-potential-oversized-13223.html Audience: Consumer, Health Professional Qualitest/Endo Health Mylan UPDATE 12/21/2012: Mylan announced a voluntary nationwide recall to the retail level of three lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg (Lots... Fri, 21 Dec 2012 05:00:00 GMT http://www.drugs.com/fda/zicam-extreme-congestion-relief-nasal-gel-recall-contamination-burkholderia-cepacia-13220.html Audience: Consumer ISSUE: Matrixx Initiatives notified the public of a recall of one lot of Zicam Extreme Congestion Relief nasal gel. Burkholderia cepacia was found in a single sample of the product taken from the affected lot. The problem was... Wed, 19 Dec 2012 05:00:00 GMT http://www.drugs.com/fda/incivek-telaprevir-combination-peginterferon-alfa-ribavirin-incivek-combination-safety-13219.html Audience: Internal Medicine, Gastroenterology, Dermatology ISSUE: FDA received reports of serious skin reactions, some fatal, in patients taking the hepatitis C drug Incivek (telaprevir) in combination with the drugs peginterferon alfa and ribavirin... Wed, 19 Dec 2012 05:00:00 GMT http://www.drugs.com/fda/pradaxa-dabigatran-etexilate-mesylate-safety-communication-should-not-patients-mechanical-13218.html Audience: Cardiology, Patients ISSUE: The U.S. Food and Drug Administration (FDA) is informing health care professionals and the public that the blood thinner (anticoagulant) Pradaxa (dabigatran etexilate mesylate) should not be used to prevent... Wed, 19 Dec 2012 05:00:00 GMT http://www.drugs.com/fda/reumofan-plus-dietary-supplement-relabeled-sold-wow-public-warning-undeclared-13217.html Audience: Consumers, Healthcare Professionals ISSUE: The U.S. Food and Drug Administration (FDA) is warning the public that the potentially harmful dietary supplement product Reumofan Plus is being relabeled and sold under the name “WOW.”  The... Wed, 19 Dec 2012 05:00:00 GMT http://www.drugs.com/fda/libigrow-libigrow-xxxtreme-blue-diamond-blue-diamond-platinum-mojo-nights-mojo-nights-supreme-13216.html Audience: Consumer [Posted 12/18/2012] ISSUE: Performance Plus Marketing, Inc. Issues a Voluntary Nationwide Recall of Libigrow, Libigrow XXXtreme, Blue Diamond, Blue Diamond Platinum, Mojo Nights, Mojo Nights Supreme, and Casanova because they... Tue, 18 Dec 2012 05:00:00 GMT http://www.drugs.com/fda/xyrem-sodium-oxybate-safety-communication-warning-against-alcohol-causing-respiratory-depression-13213.html Audience: Neurology, Internal Medicine, Patient ISSUE: FDA reminded healthcare professionals and patients that the combined use of Xyrem (sodium oxybate) with alcohol or central nervous system (CNS) depressant drugs can markedly impair consciousness... Mon, 17 Dec 2012 05:00:00 GMT http://www.drugs.com/fda/carboplatin-hospira-recall-visible-particulate-matter-identified-13214.html Audience: Pharmacy, Patient, Health Professional ISSUE: Hospira, Inc. is further informing the general public about a previously communicated voluntary user-level recall of three lots of Carboplatin Injection due to visible particulates identified... Sat, 15 Dec 2012 05:00:00 GMT http://www.drugs.com/fda/chantix-varenicline-safety-communication-updated-safety-review-risk-cardiovascular-adverse-events-13210.html Audience: Family Practice, Cardiology, Patient ISSUE: FDA is informing the public about the results of a large, combined analysis (called a meta-analysis) of clinical trials that compared patients who received the smoking cessation drug Chantix... Wed, 12 Dec 2012 05:00:00 GMT http://www.drugs.com/fda/protandim-lifevantage-corporation-recall-possible-metal-fragments-product-13209.html Audience: Consumer ISSUE: LifeVantage Corporation announced a voluntarily recall of Protandim, the Nrf2 Synergizer dietary supplement. The Company is taking this action due to the possible inclusion of small metal fragments in the final product. The... Fri, 07 Dec 2012 05:00:00 GMT http://www.drugs.com/fda/qualitest-hydrocodone-bitartrate-acetaminophen-10-mg-500-mg-recall-potential-oversized-13208.html Audience: Consumer, Health Professional ISSUE: Qualitest, a subsidiary of Endo Health Solutions, issued a voluntary nationwide recall for 101 lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg. Bottles from the affected lots... Fri, 07 Dec 2012 05:00:00 GMT http://www.drugs.com/fda/heparin-safety-communication-important-change-heparin-container-labels-clearly-state-total-13207.html Audience: Health Professionals, Patients, Home Care ISSUE: FDA is notifying health care professionals, caregivers, and patients about a change to the container and carton labels for heparin products. This label change will require manufacturers of... Thu, 06 Dec 2012 05:00:00 GMT http://www.drugs.com/fda/ondansetron-zofran-32-mg-single-intravenous-iv-updated-safety-communication-product-removal-due-13206.html Audience: Oncology, Surgery, Health Professional ISSUE: FDA is notifying health care professionals that the 32 mg, single intravenous (IV) dose of the anti-nausea drug Zofran (ondansetron hydrochloride) will no longer be marketed because of the... Tue, 04 Dec 2012 05:00:00 GMT http://www.drugs.com/fda/isovue-iopamidol-pre-filled-power-injector-syringes-bracco-diagnostics-inc-recall-presence-13204.html Audience: Risk Manager, Cardiology [Posted 11/28/2012] ISSUE: Bracco Diagnostics Inc. (BDI) is voluntarily initiating a Class I recall of nine (9) lots of Isovue (iopamidol injection) Pre-Filled Power Injector Syringes (Isovue PFS, to be used in... Wed, 28 Nov 2012 05:00:00 GMT http://www.drugs.com/fda/atorvastatin-calcium-ranbaxy-inc-recall-presence-foreign-substance-13203.html Audience: Pharmacy, Patient, Health Professional ISSUE: On November 9, 2012, Ranbaxy Inc. initiated a voluntary recall of 41 affected lots of Atorvastatin Calcium Tablets (10 mg, 20 mg and 40 mg) which is a solid oral dosage form, to the retail... Wed, 28 Nov 2012 05:00:00 GMT http://www.drugs.com/fda/pradaxa-dabigatran-etexilate-mesylate-safety-communication-safety-review-post-market-reports-13200.html Audience: Cardiology, Pharmacy, Hematology UPDATED 11/02/2012. The FDA evaluated new information about the risk of serious bleeding associated with use of the anticoagulants (blood thinners) dabigatran (Pradaxa) and warfarin (Coumadin, Jantoven, and... Fri, 02 Nov 2012 04:00:00 GMT http://www.drugs.com/fda/fungal-meningitis-outbreak-13199.html Audience: Pharmacists, Risk Managers, Pain Medicine [UPDATE 11-01-2012] Laboratory results from samples of two additional recalled NECC products – preservative free betamethasone and cardioplegia solution - have tested positive for bacterial... Thu, 01 Nov 2012 04:00:00 GMT http://www.drugs.com/fda/ameridose-llc-recall-unexpired-products-circulation-13198.html Audience: Risk Manager, Healthcare Professionals   [Posted 10/31/2012] ISSUE: The U.S. Food and Drug Administration announced today that Ameridose, LLC, based in Westborough, Mass., is voluntarily recalling all of its unexpired products in... Wed, 31 Oct 2012 04:00:00 GMT http://www.drugs.com/fda/classic-zi-xiu-tang-bee-pollen-capsules-ultimate-formula-capsules-zi-xiu-tang-success-recall-13197.html Audience: Consumers ISSUE: TZi Xiu Tang Success, LLC is voluntarily recalling four lots of Classic Zi Xiu Tang Bee Pollen Capsules, and three lots of Ultimate Formula Capsules to the consumer level. These products have been found to contain... Wed, 31 Oct 2012 04:00:00 GMT http://www.drugs.com/fda/over-counter-eye-drops-nasal-safety-communication-serious-adverse-events-accidental-ingestion-13193.html Audience: Pediatrics, Consumer ISSUE: FDA is warning healthcare professionals and the public that accidental ingestion by children of over-the-counter eye drops used to relieve redness and nasal decongestant sprays can result in serious and... Thu, 25 Oct 2012 04:00:00 GMT http://www.drugs.com/fda/fungal-meningitis-outbreak-13192.html Audience: Pharmacists, Risk Managers, Pain Medicine [UPDATE 10/24/2012]  The updated list of customers (consignees) who were shipped product on or after May 21, 2012 from the New England Compounding Center’s (NECC) Framingham, MA... Wed, 24 Oct 2012 04:00:00 GMT http://www.drugs.com/fda/fungal-meningitis-outbreak-13191.html Audience: Pharmacists, Risk Managers, Pain Medicine FDA provides NECC Customer List  [UPDATE 10/22/2012] FDA is making available two lists of customers (consignees) who received products that were shipped on or after May 21, 2012 from New England... Mon, 22 Oct 2012 04:00:00 GMT