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FDA Announces New Pediatric Dosing Guidelines for Valcyte
The U.S. Food and Drug Administration (FDA) has announced new pediatric dosing recommendations for Valcyte (valganciclovir hydrochloride) oral tablets and oral solution. This change is being made to prevent potential valganciclovir overdosing in children with low body weight, small body size, and below normal kidney function. Valganciclovir is sold under the brand name Valcyte. Valgancyclovir is an antiviral medication that can be effective for the prevention of cytomegalovirus (CMV) disease in children 4 months to 16 years of age who have undergone a kidney or heart transplant. Cytomegalovirus is a member of a group of herpes-type viruses that can cause disease in different parts of the body. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm225727.htm
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FDA Sends Warning Letters to Makers of Electronic Cigarettes
The FDA has issued warning letters to five manufacturer's of electronic cigarettes: E-Cigarette Direct LLC, Ruyan America Inc., Gamucci America (Smokey Bayou Inc.), E-Cig Technology Inc., and Johnson's Creek Enterprises LLC. Electronic cigarettes (also known as e-cigarettes) are battery-operated devices designed to look like and to be used in the same manner as conventional cigarettes. The e-cigarette violations included unsupported claims and poor manufacturing practices. The FDA is concerned because e-cigarettes have not been evaluated for safety or effectiveness. In a review of the manufacturing plants, the FDA also found serious quality issues that indicate that quality control processes used to manufacture these products are below standard or do not exist. The FDA plans to regulate electronic cigarettes and related products in a manner consistent with regulation of other nicotine products. The FDA has invited electronic cigarette firms to work in cooperation with the agency toward the goal of assuring that electronic cigarettes sold in the United States are safe, effective, and lawfully marketed. The FDA has answered several common questions about the e-cigarette issue. To view the FDA's "E-Cigarettes: Questions and Answers", please visit: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm225210.htm For more information from the FDA, please visit: http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm172906.htm
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Date Published Title Drug Source
2010-09-16 FDA Announces New Pediatric Dosing Guidelines for Valcyte Valganciclovir FDA
2010-09-11 FDA Sends Warning Letters to Makers of Electronic Cigarettes FDA
2010-08-20 FDA: Ongoing Safety Review of Stalevo and Possible Increased Risk of Heart Attack and Stroke Entacapone FDA
2010-08-17 Companies Failed To Prove Benefits of Midodrine (ProAmantine) Midodrine Hydrochloride FDA
2010-08-16 Proctor & Gambles Recalls Select Lots of Vicks Sinex Nasal Spray Oxymetazoline FDA
2010-08-15 Single Lot of ShopKo Cold/Flu Relief Multi Symptom Night Time Original Recalled Acetaminophen with Dextromethorphan and Doxylamine FDA
2010-08-15 Allergan Recalls Acuvail Eye Drops Ketorolac FDA
2010-08-12 FDA: Aseptic Meningitis Risk with Use of Seizure Drug Lamictal Lamotrigine FDA
2010-08-11 Teva Recalls Select Lots of Amoxicillin for Oral Suspension, 400 mg/5 mL Amoxicillin FDA
2010-08-11 Wellbutrin XL 150 mg: Single Lot Recalled Bupropion FDA
2010-08-11 2010-2011 Flu Vaccine: What Consumers Should Know Influenza Vaccine FDA
2010-08-05 Delay in Results From FDA's Ongoing Safety Review of Stimulant Medications used in Children with ADHD Lisdexamfetamine FDA
2010-08-05 FDA Warns: Nimodipine Is for Oral or Feeding Tube Use Only Nimodipine FDA
2010-07-30 Apotex Corp.Recalls Single Lot of Carbamazepine Tablets 200 mg Carbamazepine FDA
2010-07-30 Paddock Laboratories, Inc. Recalls Single Lot of LiothyronineTablets Liothyronine FDA
2010-07-30 McNeil Healthcare Recalls Additional Lot of Motrin IB Ibuprofen FDA
2010-07-30 Vintage Pharmaceuticals LLC Recalls Single Lot of Ibudone, 5 mg/200 mg tablets Hydrocodone Bitartrate with Ibuprofen FDA
2010-07-29 The FDA Announces Ongoing Safety Review of Evamist and Reports of Unintended Exposure of Children and Pets Estradiol FDA
2010-07-29 FDA Warns about Risk of Developing Rare Type of Pneumonia During Treatment With Cubicin Daptomycin FDA
2010-07-28 Bausch + Lomb Recalls PreserVision Eye Vitamin AREDS 2 Formula with Omega 3 Soft Gel VIT A / VIT C / VIT E / Copper / Zinc Manufacturer
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