Safety Alerts & Recalls

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FDA Warns About Risks of Lexiscan (Regadenoson) and Adenoscan (Adenosine)
The U.S. Food and Drug Administration (FDA) is warning healthcare professionals of the rare but serious risk of heart attack and death with use of the cardiac nuclear stress test agents Lexiscan and Adenoscan. Lexiscan and Adenoscan are FDA approved for use during cardiac nuclear stress tests in patients who cannot exercise adequately. Lexiscan and Adenoscan help identify coronary artery disease. These drugs dilate the coronary arteries and increase blood flow so that coronary artery obstructions can be identified. The prescribing information for Lexiscan and Adenoscan will be updated to advise healthcare professionals to avoid using these drugs in patients with signs or symptoms of unstable heart conditions including unstable angina and cardiovascular instability since these conditions may place patients at a greater risk for serious heart-related adverse reactions. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm375654.htm
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Perrigo Recalls Several Store Brands of Acetaminophen Infant Suspension Liquid Due to Potential Defect with the Oral Syringe Included in Packaging
The Perrigo Company announced that it has issued a voluntary, nationwide product recall of 18 lots of its Acetaminophen Infant Suspension Liquid, 160 mg/5 mL, sold in 2 oz. and 4 oz. bottles with oral dose syringes. This recall includes products made by Perrigo but sold in a box under several store brands such as Babies R Us, Care One, Target Up & Up, Walmart Equate, and more. The Acetaminophen Infant Suspension Liquid product brand names and lot numbers listed below have been recalled because of the possibility that a small number of packages might contain an oral dosing syringe without dose markings. Using an oral syringe without dose markings can result in inaccurate dosing, especially in infants who could mistakenly get too high of a dose. Label Name – Recalled Lot Number(s) BABIES R US – Lot KK0606 CARE ONE – Lot 3HK0564 EQUALINE – Lot 3HK0672 EQUATE – Lots 3HK0672, 3JK0433, 3JK0594, 3JK0595, 3JK0653, 3JK0673, 3KK0815, 3KK0817 HARMON FACE VALUES – Lot 3JK0594 HEALTH MART – Lot 3HK0671 HEALTHY ACCENTS – Lots 3HK0671, 3KK0606 HEB – Lot 3KK0606 KROGER – Lots 3GK0645, 3GK0704, 3HK0671, 3JK0433, 3JK0595, 3JK0653, 3JK0433, 3JK0595, 3GK0645, 3GK0704, 3JK0595 LEADER DRUG – Lots 3JK0433, 3JK0594 MEIJER – Lots 3JK0594, 3JK0597 PUBLIX – Lot 3JK0595 RITE AID – Lot 3GK0704 TARGET UP & UP – Lot 3HK0672 TOPCARE – Lots 3KK0359, 3KK0494 WALGREEN – Lots 3GK0704, 3HK0564, 3HK0671, 3JK0433, 3JK0595, 3JK0610, 3KK0360 Acetaminophen is indicated for the relief of fever and minor aches and pains and can be used in infants, children and adults. This recall only involves the above brands and lot numbers. No other acetaminophen products were involved in this recall. For more information, please visit: http://www.fda.gov/Safety/Recalls/ucm373338.htm
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Date Published Title Drug Source
2013-11-21 FDA Warns About Risks of Lexiscan (Regadenoson) and Adenoscan (Adenosine) Adenosine 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
2013-11-01 FDA Adds Black Box Warning and Updates Warnings for Anti-Seizure Medicine Potiga (Ezogabine) Ezogabine FDA
2013-11-01 FDA Asks Manufacturer to Stop Sales of Its Leukemia Drug Iclusig (Ponatinib) Ponatinib FDA
2013-10-25 FDA Works to Put Tighter Controls on Hydrocodone Combination Pain Killers Hydrocodone FDA
2013-10-25 FDA To Complete Phase-Out of Chlorofluorocarbon Inhalers Including Combivent Inhalation Aerosol and Maxair Autohaler. Maxair FDA
2013-10-18 Nephron Pharmaceuticals Announces Recall of Albuterol Sulfate Inhalation Solution, 0.083% Albuterol FDA
2013-10-14 FDA Warns of Increased Reports of Serious Blood Clots with Iclusig (Ponatinib) Ponatinib FDA
2013-09-30 New Boxed Warning for Anti-Cancer Drugs Arzerra (Ofatumumab) and Rituxan (Rituximab) Rituximab FDA
2013-09-30 Combo-Medicine Juvisync Production Discontinued Sitagliptin and Simvastatin FDA
2013-09-30 FDA Warns: Do Not Use Budesonide Nasal Irrigation from The Compounding Shop Budesonide Inhalation FDA
2013-09-30 FDA Adds New Boxed Warning, Warns of Increased Risk of Death with Tygacil (Tigecycline) Tigecycline FDA
2013-09-25 Changes to Duragesic (Fentanyl) Packaging to Reduce Risk of Accidental Exposure Fentanyl FDA
2013-08-30 Consumers Warned Not to Purchased Ortiga, an Unapproved Product Diclofenac FDA
2013-08-29 FDA Investigating Report of Progressive Multifocal Leukoencephalopathy (PML) in Patient Taking Gilenya (Fingolimod) Fingolimod FDA
2013-08-19 FDA Strengthens Neuropathy Warnings for Fluoroquinolone Class of Antibiotics Gemifloxacin FDA
2013-08-05 FDA Warns of Rare But Serious Skin Reaction with Acetaminophen FDA
2013-08-05 FDA Warns: Purity First’s Expands Recall and Now Includes Healthy Life Chemistry B-50, Vitamin C and Multi-Mineral Vitamin B Complex FDA
2013-07-30 Nova Diabetes Care Recalls of Several Lots of Nova Max Glucose Test Strips Tolazamide Manufacturer
2013-07-29 FDA Strengthens Warnings for Antimalarial Drug Mefloquine For Serious Psychiatric and Nerve Side Effects Mefloquine FDA
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