Safety Alerts & Recalls

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FDA Update: Avandia, Avandamet and Avandaryl Labels Now Include Information About Heart-Related Risks, Patient Access Restrictions Expected Later This Year
The U.S. Food and Drug Administration (FDA) is notifying the public that the prescribing information and patient Medication Guide for the diabetes drug rosiglitazone has been updated to include information on heart-related risks, including the risk of heart attack, associated with this medicine. This safety information was first announced by FDA on September 23, 2010. Rosiglitazone is sold as a single-ingredient product under the brand name Avandia. Rosiglitazone is also sold as a combination product under the brand name Avandamet (contains rosiglitazone and metformin) and under the brand name Avandaryl (contains rosiglitazone and glimepiride). In addition to describing the heart-related risks, the drug labels have been revised to state that rosiglitazone and rosiglitazone-containing medicines should only be used: -In patients already being treated with these medicines -In patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare professional, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact). At this time, FDA has only approved these safety-related changes to the prescribing information and Medication Guides for the rosiglitazone-containing medicines. The program to restrict the availability of rosiglitazone-containing medicines has not yet been approved and formally implemented. The FDA will be providing further information on this program in the coming months. FDA expects to approve the program by Spring 2011, and for the manufacturer to complete implementation 6 months thereafter. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm241411.htm
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Qualitest Recalls Phenobarbital Tablets Because of Incorrect Package Labeling
Qualitest Pharmaceuticals has issued a voluntary nationwide recall of Phenobarbital Tablets, USP 32.4mg, NDC 0603-5166-32, lot numbers T150G10B, T120J10E and T023M10A. These lots of Phenobarbital Tablets, 32.4mg are being recalled because an individual bottle of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count was found incorrectly labeled as Phenobarbital Tablets USP, 32.4mg, NDC 0603-5166-32, 1000 count. As a result of this mix-up, patients may unintentionally take Hydrocodone and acetaminophen tablets, instead of the intended dose of Phenobarbital. Unintentional administration of Hydrocodone can lead to serious adverse events including respiratory depression (slowed breathing), depression of the central nervous system (drowsiness, slower heart rate, loss of motor skills, unclear speech, unclear thinking and unclear vision), coma, and death, especially in opioid naive patients and patients on other medicines that cause depression of the central nervous system. Unintentional administration of acetaminophen may result in liver toxicity in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day. Additionally, missing doses of Phenobarbital could result in loss of seizure control. Phenobarbital is used to prevent seizures. It is made by many different manufacturers and comes in several strengths. This recall alert only applies to the select lots of the Phenobarbital Tablets, USP 32.4mg, NDC 0603-5166-32, 1000 count from Qualitest. No other Phenobarbital products are involved in this recall. For more information, please visit: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm242527.htm and http://www.fda.gov/Safety/Recalls/ucm242398.htm
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Date Published Title Drug Source
2011-02-04 FDA Update: Avandia, Avandamet and Avandaryl Labels Now Include Information About Heart-Related Risks, Patient Access Restrictions Expected Later This Year Glimepiride and Rosiglitazone FDA
2011-02-07 Qualitest Recalls Phenobarbital Tablets Because of Incorrect Package Labeling Phenobarbital FDA
2011-02-07 Qualitest Recalls Hydrocodone Bitartrate And Acetaminophen Tablets Because of Incorrect Package Labeling Hydrocodone with Acetaminophen FDA
2011-02-07 Watson Informs Customers of Important Information About Alcohol Prep Pads in Trelstar Kits Triptorelin FDA
2011-02-17 Janssen Recalls 10 Lots of Invega Sustenna Syringes Paliperidone FDA
2011-02-18 Terbutaline: Change To the Prescribing Information - Boxed Warning Against Use for Treatment of Preterm Labor Terbutaline FDA
2011-02-18 Upsher-Smith Announces Nationwide Recall Of Jantoven Warfarin Sodium Tablets, 3mg, Due To Mislabeled Bottles Warfarin FDA
2011-02-22 Labeling Change for all Antipsychotic Medications: Warnings Regarding Use During Pregnancy Moban FDA
2011-02-24 Upsher-Smith Expands Recall of Jantoven to Include More Tablet Strengths and Other Products Oxybutynin FDA
2011-02-24 Upsher-Smith Expands Recent Recall to Include: Amantadine, Amlodipine, Androxy, Baclofen, Bethanechol, and Oxybutynin Oxybutynin FDA
2011-02-24 Roche Announces Recall of ACCU-CHEK FlexLink Plus Infusion Sets Insulin Aspart FDA
2011-02-25 Recall of Certain Lots of SUDAFED 24 Hour Pseudoephedrine Manufacturer
2011-03-01 Nycomed Recalls Single Lot of Fluticasone Propionate Ointment, 0.005% Fluticasone FDA
2011-03-01 Nycomed Recalls Single Lot of Fluticasone Propionate Ointment, 0.005% Fluticasone Topical FDA
2011-03-01 FDA Review of Abacavir Finds No Increased Risk of Heart Attack Abacavir with Lamivudine FDA
2011-03-02 FDA Warns: Low Magnesium Levels Can Be Associated With Long-Term Use of Prescription Proton Pump Inhibitors Dexlansoprazole FDA
2011-03-05 FDA Warns About Risk of Oral Birth Defects in Children Born to Mothers Taking Topiramate Topiramate FDA
2011-03-05 Teva Pharmaceuticals Recalls Several Lots of Nifediac CC (nifedipine), Extended Release Tablets, 30 mg, 60 mg and 90 mg Nifedipine FDA
2011-03-05 Glenmark Generics Inc. Recalls Several Lots of Alclometasone Dipropionate Ointment USP, 0.05% Alclometasone FDA
2011-03-05 Marlex Pharmaceuticals and Cispharma Inc. Recall Select Lots of Acetaminophen Tablets, 325mg Acetaminophen FDA