Safety Alerts & Recalls

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Allergan Issues Voluntary Recall of Select Lots Of REFRESH Lacri-Lube, REFRESH P.M., FML, and Blephamide Over Safety Concerns
Allergan is conducting a voluntary of certain lots of the following eye treatment products: -- REFRESH Lacri-Lube 3.5g and 7g for dry eye -- REFRESH P.M. 3.5g for dry eye -- FML 0.1% 3.5 g, an anti-inflammatory topical ophthalmic ointment -- Blephamide 10%/0.2% 3.5g, an ophthalmic ointment combining an antibiotic and a corticosteroid Allergan chose to issue this recall based on a small number of customer complaints of a small black particle at the time of use. This black particle may be created when unscrewing the cap from the aluminum tube. The company said complaints include 12 reports of a foreign body in the eye, two reports of eye irritation, and two reports of product contamination. For more information and to view a list of recalled products and lot numbers, please visit: http://www.fda.gov/Safety/Recalls/ucm459485.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
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FDA Warns About Possible New Side Effect of SGLT2 Inhibitors
In a recent safety announcement, the U.S. Food and Drug Administration (FDA) warned about possible ketoacidosis caused by the class of type 2 diabetes medications called sodium-glucose cotransporter-2 (SGLT2) inhibitors. These include the medications containing empagliflozin (Jardiance, Glyxambi), dapagliflozin (Farxiga, Xigduo XR), and canagliflozin (Invokana, Invokamet). Ketoacidosis is a serious condition in which the body produces high levels of blood acids called ketones that may require hospitalization. The FDA is continuing to investigate this safety issue and will determine whether changes are needed in the prescribing information for this class of medications. Until now it was not known that SGLT2 inhibitors could trigger ketoacidosis and this information is not found in the product information. SGLT2 inhibitors are approved for the treatment of type 2 diabetes. Patients with type 2 diabetes are usually not at risk for developing spontaneous ketoacidosis and may not recognize the early symptoms. The FDA is advising doctors to inform their patients about ketoacidosis and its symptoms. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm446845.htm
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Date Published Title Drug Source
2015-08-25 Allergan Issues Voluntary Recall of Select Lots Of REFRESH Lacri-Lube, REFRESH P.M., FML, and Blephamide Over Safety Concerns Fluorometholone FDA
2015-05-27 FDA Warns About Possible New Side Effect of SGLT2 Inhibitors Canagliflozin / Metformin FDA
2015-03-05 FDA Cautions About Using Testosterone Products for Low Testosterone Due to Aging; Possible Increased Risk of Heart Attack and Stroke Methyltestosterone FDA
2014-12-11 FDA Warns Ziprasidone (Geodon) May Cause Rare but Serious Skin Reactions Ziprasidone FDA
2014-11-26 FDA Warns About Case of Progressive Multifocal Leukoencephalopathy (PML) With MS Drug Tecfidera (Dimethyl Fumarate) Dimethyl Fumarate FDA
2014-11-25 Empty Gabapentin 300 mg Capsules From Aurobindo Pharma Prompt Recall Gabapentin FDA
2014-11-17 FDA Reviews Recently Published Study Data for Long-term Antiplatelet Therapy Clopidogrel (Plavix) or Prasugrel (Effient) Prasugrel FDA
2014-11-17 FDA Reviews Recently Published Study Data for Long-term Antiplatelet Therapy Clopidogrel (Plavix) or Prasugrel (Effient) Prasugrel FDA
2014-11-14 FDA Raises Concern About Generic Extended-Release Methylphenidate Hydrochloride Tablets (generic Concerta) made by Mallinckrodt and Kudco Methylphenidate FDA
2014-07-03 Oral Lidocaine for Teething Pain May Cause Harm Lidocaine FDA
2014-06-30 FDA Warns That Over-the-Counter Topical Acne Medicines May Cause Serious Allergic Reactions Benzoyl Peroxide FDA
2014-06-26 FDA Warns: Docetaxel May Cause Alcohol Intoxication Docetaxel FDA
2014-06-24 FDA Adds Blood Clot Warning to Testosterone Products Methyltestosterone FDA
2014-06-13 Diabetic Supply of Suncoast, Inc. Recalls Advocate Redi-Code+ BMB-BA006A Blood Glucose Test Strips Manufacturer
2014-06-13 Diabetic Supply of Suncoast, Inc. Recalls Advocate Redi-Code+ BMB-BA006A Blood Glucose Test Strips Tolazamide Manufacturer
2014-05-21 FDA Requests Seizure of Unapproved Drugs Marketed by Ascend Laboratories of Montvale, NJ Hydrocortisone with Pramoxine FDA
2014-05-19 FDA Requires Lower Starting Dose of Lunesta (eszopiclone) to Reduce Risk of Next-Day Impairment Eszopiclone FDA
2014-05-14 FDA Completes Study Reviewing Efficacy and Safety of Pradaxa® (dabigatran) Dabigatran FDA
2014-05-08 Alere Recalls Alere INRatio®2 PT/INR Professional Test Strips Warfarin FDA
2014-05-07 FDA Addresses the Question: “Can an Aspirin a Day Help Prevent a Heart Attack?” Aspirin FDA