Safety Alerts & Recalls

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FDA Alerts Pharmacists and Health Care Professionals to Potential for Mix-up when Dispensing the Drugs Durezol and Durasal
The U.S. Food and Drug Administration (FDA) is alerting pharmacists and other health care professionals of potential injury due to confusion between the FDA-approved eye medicine Durezol (difluprednate ophthalmic emulsion) 0.05% and the topical wart remover Durasal (salicylic acid) 26%. There has been one report of serious injury when a pharmacist mistakenly gave an eye surgery patient Durasal, the salicylic acid–containing wart remover, instead of the prescribed Durezol eye drops. Durezol is approved for treatment of inflammation and pain association with ocular surgery. Several other cases were reported arising from confusion between Durezol and Durasal. In some cases, the error was discovered prior to the medication reaching the patient. Due to the potential for confusion between these two products, the FDA warns pharmacists to pay close attention when filling prescriptions, especially for the ophthalmic solution Durezol. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm285235.htm
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Know Concentration Before Giving Acetaminophen to Infants: Additional Concentration of Liquid Acetaminophen (160 mg/5 mL) Now Available
The Food and Drug Administration (FDA) is urging consumers to carefully read the labels of liquid acetaminophen (also known by brand name Tylenol) marketed for infants to avoid giving the wrong dose to their children. A less concentrated form of the medication is arriving on store shelves, and giving the wrong dose of acetaminophen can cause the medication to be ineffective if too little is given or cause serious side effects and, possibly, death if too much is given. In an attempt to reduce the confusion over different strengths that have been blamed for past overdoses, some manufacturers are making a switch and offering only the less concentrated version for all children. Until now, liquid acetaminophen marketed for infants has only been available in a stronger concentration that doesn’t require giving the infants as much liquid with each dose. But right now both concentrations of liquid acetaminophen are available. The FDA is concerned that infants could be given too much or too little of the medicine if the different concentrations of acetaminophen are confused. For more information, please visit: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm284563.htm?source=govdelivery and http://www.fda.gov/Drugs/DrugSafety/ucm284741.htm
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Date Published Title Drug Source
2011-12-29 FDA Alerts Pharmacists and Health Care Professionals to Potential for Mix-up when Dispensing the Drugs Durezol and Durasal Salicylic Acid FDA
2011-12-27 Know Concentration Before Giving Acetaminophen to Infants: Additional Concentration of Liquid Acetaminophen (160 mg/5 mL) Now Available Acetaminophen FDA
2011-12-27 Know Concentration Before Giving Acetaminophen to Infants: Additional Concentration of Liquid Acetaminophen (160 mg/5 mL) Now Available FDA
2011-12-22 Eclectic Institute Recall Specific Dietary Supplements Containing Gotu Kola (Centella Asiatica) And Bladderwrack (Fucus Vesiculosus) Due to Possible Bacteria Contamination FDA
2011-12-22 McNeil Recalls Certain Lots of Motrin Ibuprofen Manufacturer
2011-12-22 Nycomed Recalls Select Lots of Omnaris (ciclesonide) Nasal Spray, 50mcg Ciclesonide Nasal FDA
2011-12-20 FDA Announces Safety Review of a Reported Death After the First Dose of Gilenya Fingolimod FDA
2011-12-19 FDA Completes Safety Review of Multaq and Updates Prescribing Information Dronedarone FDA
2011-12-15 FDA Revises Dose Limitation for Zocor (simvastatin) When Taken with Amiodarone Simvastatin FDA
2011-12-15 FDA Update: Safety Information for Antidepressant Use During Pregnancy Paroxetine FDA
2011-12-14 FDA Warns HCG Diet Products Are Illegal FDA
2011-12-14 Novartis Looking into Death of MS Patient Who Took Gilenya Fingolimod MediGuard CRT
2011-12-08 FDA Evaluating Reports of Bleeding in Patients Taking Pradaxa Dabigatran FDA
2011-12-06 Corepharma LLC Recalls Several Lots of Ropinirole Hydrochloride Tablets, 0.25, 0.5, 1, 2 mg Ropinirole FDA
2011-12-06 G & W Laboratories Inc. Recalls Single Lot of Migergot (Ergotamine Tartrate and Caffeine Suppositories) Caffeine with Ergotamine Tartrate FDA
2011-11-21 FDA Announces Avastin Not Shown to Be Safe and Effective in Breast Cancer Patients Bevacizumab FDA
2011-11-17 FDA Requests a Stop to the Distribution of Pennsaid Samples Diclofenac FDA
2011-11-09 FDA: Trilipix (fenofibric acid) May Not Lower a Patient's Risk of Having a Heart Attack or Stroke Fenofibric Acid FDA
2011-11-09 Manufacturing Delays May Affect Availability of Antibiotic Tetracycline Tetracycline FDA
2011-11-09 FDA Issues Safety Review Update of Medications Used to Treat Attention-Deficit/Hyperactivity Disorder (ADHD) Atomoxetine FDA