Safety Alerts & Recalls

Search all Safety Alerts & Recalls

Latest Alerts

Paddock Recalls Select Lots of Compro Prochlorperazine Suppositories At Warehouse/Retail Level
Paddock Laboratories, Inc. is recalling two lots of Compro prochlorperazine suppositories, USP 25 mg. Lot numbers 9116177 and 8172830 are being recalled because samples from these lots failed tests that measured their ability to dissolve. Compro contains the active ingredient prochlorperazine and is most commonly used to prevent and treat nausea and vomiting. This recall alert only applies these two lots of Compro 25 mg Suppositories. No other Compro or prochlorperazine products are involved in this recall. To view the FDA notice about this recall, please visit: http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm202904.htm
Learn More

FDA Makes Statement on the ACCORD Lipid Trial
The U.S. Food and Drug Administration (FDA) announced that it will review the primary results from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid Trial. The ACCORD Lipid Trial evaluated the potential heart related benefits in patients with type 2 diabetes mellitus taking simvastatin plus fenofibrate (also marketed as Tricor, Antara, Triglide, and others). The ACCORD Lipid Trial looked at how often major heart disease related events (heart attack, stroke, heart disease related death) occurred in patients receiving simvastatin plus fenofibrate, compared to simvastatin alone. All patients in the study had a history of type 2 diabetes mellitus, were at high risk for heart disease, and were followed almost 5 years on average. The trial found that there was no difference in the heart disease related outcomes between the two groups. At this time the FDA has made no new conclusions or recommendations regarding the combination use of simvastatin or other statin drugs and fenofibrate. The FDA will conduct a full review of the ACCORD study results as soon as they become available. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203681.htm
Learn More

Date Published Title Drug Source
2010-03-16 Paddock Recalls Select Lots of Compro Prochlorperazine Suppositories At Warehouse/Retail Level Prochlorperazine FDA
2010-03-15 FDA Makes Statement on the ACCORD Lipid Trial Fenofibrate FDA
2010-03-15 FDA Makes Statement on the ACCORD Lipid Trial Fenofibric Acid FDA
2010-03-12 FDA Adds Boxed Warning to Plavix (Clopidogrel) Clopidogrel FDA
2010-03-11 FDA Publishes Results of Ongoing Safety Review of Oral Bisphosphonates and Femur Fractures Alendronate FDA
2010-03-11 Black Box Warning for WinRho SDF Warns About Potentially Life Threatening Reaction WinRho SDF Manufacturer
2010-03-05 FDA Approves Name Change for Heartburn Drug Kapidex Dexlansoprazole FDA
2010-03-02 Wyeth Recalls Several Lots of Effexor XR 37.5 mg, 75 mg, and 150 mg Capsules Venlafaxine FDA
2010-03-01 Updated "Mifeprex Question and Answers" on FDA Website Mifepristone FDA
2010-03-01 LifeScan Recalls Eight Lots of OneTouch SureStep Test Strips Due To Falsely Low Readings Insulin Manufacturer
2010-02-23 The FDA Is Reviewing A Possible Safety Concern for HIV Drug Combination of INVIRASE with NORVIR Saquinavir FDA
2010-02-23 Ongoing Review of AVANDIA (ROSIGLITAZONE) and Cardiovascular Safety Rosiglitazone FDA
2010-02-19 Recall of Two Lots of PREMPRO 0.3 mg/1.5 mg EZ-DIAL Dispensers Estrogens Conjugated with Medroxyprogesterone FDA
2010-02-19 Recall of a Single Lot of Pilocarpine Hydrochloride 5 mg Tablets Pilocarpine FDA
2010-02-19 Recall of Four Lots of ANTIBACTERIAL WASHCLOTHS Containing Benzalkonium Chloride FDA
2010-02-18 Boxed Warning and Other Changes to the EXJADE Prescribing Information Deferasirox Manufacturer
2010-02-18 New Safety Requirements for Long-acting Inhaled Asthma Medications Called Long-Acting Beta-Agonists (LABAs) Formoterol with Budesonide FDA
2010-02-18 Product Confusion with Maalox Total Relief and Maalox Liquid Products Aluminium Hydroxide with Magnesium Hydroxide FDA
2010-02-17 Statin Benefits Still Outweigh New Safety Information Atorvastatin MediGuard CRT
2010-02-16 The FDA Requires a Risk Management Program for Erythropoiesis-Stimulating Agents (ESAs) Epoetin Alfa FDA