Safety Alerts & Recalls

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Latest Alerts

Consumers Warned Not to Purchased Ortiga, an Unapproved Product
The Food and Drug Administration (FDA) is advising consumers not to purchase or use Ortiga, an unapproved product promoted for a variety of health conditions and sold on multiple websites, including www.ebay.com, and in some retail stores. The product is manufactured in Mexico and labeled primarily in Spanish. The FDA laboratory analysis confirmed that Ortiga contains the prescription drug ingredient, diclofenac. Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products. For more information, please visit: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm365991.htm
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Changes to Duragesic (Fentanyl) Packaging to Reduce Risk of Accidental Exposure
The Food and Drug Administration (FDA) is requiring color changes to the writing on Duragesic (fentanyl) pain patches so it can be seen more easily. This is part of an effort to prevent accidental exposure to the patches, which can cause serious harm and death in children, pets, and others. The manufacturer of Duragesic will be required to print the name and strength of the drug on the patch in long-lasting ink, in a color that is clearly visible to patients and caregivers. The current ink color varies by strength and is not always easy to see. This change is expected to make it easier find patches on patients’ bodies and to locate patches that have fallen off, which children or pets could accidentally touch or ingest. The manufacturers of generic fentanyl patches are being asked to make similar changes. The Duragesic (fentanyl) patch is a strong prescription pain medicine that contains a narcotic opioid. It is marketed under the brand-name Duragesic and also as generic products. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm368902.htm and http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm300803.htm
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Date Published Title Drug Source
2013-08-30 Consumers Warned Not to Purchased Ortiga, an Unapproved Product Diclofenac FDA
2013-09-25 Changes to Duragesic (Fentanyl) Packaging to Reduce Risk of Accidental Exposure Fentanyl FDA
2013-09-30 FDA Adds New Boxed Warning, Warns of Increased Risk of Death with Tygacil (Tigecycline) Tigecycline FDA
2013-09-30 FDA Warns: Do Not Use Budesonide Nasal Irrigation from The Compounding Shop Budesonide Inhalation FDA
2013-09-30 Combo-Medicine Juvisync Production Discontinued Sitagliptin and Simvastatin FDA
2013-09-30 New Boxed Warning for Anti-Cancer Drugs Arzerra (Ofatumumab) and Rituxan (Rituximab) Rituximab FDA
2013-10-14 FDA Warns of Increased Reports of Serious Blood Clots with Iclusig (Ponatinib) Ponatinib FDA
2013-10-18 Nephron Pharmaceuticals Announces Recall of Albuterol Sulfate Inhalation Solution, 0.083% Albuterol FDA
2013-10-25 FDA To Complete Phase-Out of Chlorofluorocarbon Inhalers Including Combivent Inhalation Aerosol and Maxair Autohaler. Maxair FDA
2013-10-25 FDA Works to Put Tighter Controls on Hydrocodone Combination Pain Killers Hydrocodone FDA
2013-11-01 FDA Asks Manufacturer to Stop Sales of Its Leukemia Drug Iclusig (Ponatinib) Ponatinib FDA
2013-11-01 FDA Adds Black Box Warning and Updates Warnings for Anti-Seizure Medicine Potiga (Ezogabine) Ezogabine FDA
2013-11-04 Perrigo Recalls Several Store Brands of Acetaminophen Infant Suspension Liquid Due to Potential Defect with the Oral Syringe Included in Packaging Acetaminophen FDA
2013-11-21 FDA Warns About Risks of Lexiscan (Regadenoson) and Adenoscan (Adenosine) Adenosine FDA
2013-11-27 FDA Removes Some Prescribing and Dispensing Restrictions For Rosiglitazone-Containing Medicines, Including Avandia, Avandamet, and Avandaryl Glimepiride and Rosiglitazone FDA
2013-12-03 FDA Warns of Risk of Serious Skin Reactions with Onfi (Clobazam) Clobazam FDA
2013-12-17 FDA Warns of Rare Risk of Priapism Associated with Methylphenidate Products Dexmethylphenidate FDA
2014-01-02 FDA Requires New Safety Measures for Iclusig (Ponatinib) Before It Can Return to Market Ponatinib FDA
2014-01-08 FDA Warns of Possible Harm From Exceeding Dose of Over-the-Counter Enemas and Oral Solutions Used to Treat Constipation FDA
2014-01-10 Nipro Recalls TRUEtrack and TRUEbalance Glucose Meters Insulin Aspart FDA