Safety Alerts & Recalls

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Latest Alerts

Companies Failed To Prove Benefits of Midodrine (ProAmantine)
The U.S. Food and Drug Administration (FDA) has proposed to withdraw the approval of the low-blood pressure medicine midodrine (ProAmantine) because required post-marketing studies on the drug's effectiveness have not been done. Midodrine was approved under the FDA's accelerated approval program for drugs that treat serious or life-threatening diseases. This program requires that the manufacturer verify benefits to patients through post-marketing studies. Midodrine is used to treat the low blood pressure condition called orthostatic hypotension. Midodrine is marketed as ProAmatine by Shire Development Inc. and generic versions of the drug are made by Apotex Corp., Impax Laboratories Inc., Mylan Pharmaceuticals, Sandoz Inc., and Upsher-Smith Laboratories. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm222640.htm and http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm222580.htm
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Proctor & Gambles Recalls Select Lots of Vicks Sinex Nasal Spray
Proctor & Gamble has recalled several lots of its nasal decongestant Vicks Sinex Spray because the product formulation may not meet the expiration dates on the package. The recalled lots also may contain floating particles of chlorhexidine, a preservative used to prevent the growth of bacteria. The recalled product was distributed under the labels 1) Vicks Sinex VapoSpray, 4 Hour Decongestant, 2) Vicks Sinex Nasal Spray, For Sinus Relief, and 3) Vicks Sinex Ultra Fine Mist, For Sinus Relief. The following lots were involved in the recall: 01171720K1 0117PR; 00601720K1 0060PR; 00571720K1 0057PR; 00511720K1 0051PR; 00461720K1 0046PR; 93271720K1 9327PR; 93151720K1 9315PR; 92921720K1 9292PR; 92901720K1 9290PR; 92721720K1 9272PR; 92611720K1 9261PR; 92601720K1 9260PR; 92591720K1 9259PR; 92311720K1 9231PR; 92271720K1 9227PR; 92261720K1 9226PR; 92081720K1 9208PR; 91821720K1 9182PR; 91801720K1 9180PR; 91601720K1 9160PR; 91381720K1 9138PR; 90781720K1 9078PR; 90761720K1 9076PR; 90491720K1 9049PR; 90481720K1 9048PR; 90191720K1 9019PR; 83241720K1 8324PR; 83231720K1 8323PR; 83181720K1 8318PR; 82941720K1 8294PR; 82911720K1 8291PR; 82521720K1 8252PR; 82491720K1 8249PR; 82481720K1 8248PR; 82241720K1 8224PR; 82011720K1 8201PR; 82001720K1 8200PR; 81991720K2 8199PR; 81851720K2 8185PR; 81851720K1 8185PR; 81431720K1 8143PR; 81421720K1 8142PR; 80771720K1 8077PR; 73371720K1 7337PR; 73161720K1 7316PR; 73061720K1 7306PR; 72911720K1 7291PR; 72841720K1 7284PR; 72601720K1 7260PR; 72561720K1 7256PR; 72281720K2 7228PR; 72231720K1 7223PR; and 72221720K1 7222PR. The Vicks Sinex Sprays are used to treat nasal symptoms from colds and allergies. This recall alert only applies to the select lots of Vicks Sinex Spray. No other allergy or cold products were involved in this recall. To view the FDA notice about this recall, please visit: http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm222069.htm
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Date Published Title Drug Source
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
2010-07-23 FDA Publishes Question and Answers about Approval of Generic Version of Lovenox (Enoxaparin Sodium Injection) Lovenox FDA
2010-07-21 Glumetza: Depomed Inc. Recalls Several Lots Metformin FDA
2010-07-21 Two Companies Recall Their Isosorbide Mononitrate Product Isosorbide FDA