Food and Drug Administration - Recalls

Proton Pump Inhibitors (PPIs) - Drug Safety Communication: Clostridium Difficile-Associated Diarrhea (CDAD) Can be Associated With Stomach Acid Drugs

02/08/2012 10:15 AM
Symptoms may include watery stool, abdominal pain, and fever. Patients may go on to develop more serious intestinal conditions.

H & P Industries Povidone Iodine Prep Pads: Recall - Potential Microbial Contamination

02/08/2012 09:27 AM
UPDATED 02/08/2012. NAR Surgical Crichothyroidotomy (Crickit) Kits recalled. Use of contaminated Povidone Prep Pads could lead to life-threatening infections.

Healthy People Co. Dietary Supplements: Recall - Undeclared Drug Ingredient

02/06/2012 10:00 AM
Recalled products pose significant risk to patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.

Gris-PEG (griseofulvin ultramicrosize): Health Advisory - Risk of Product Mix-Up

02/03/2012 05:18 PM
During packaging and labeling, tablets from one product type may have carried over into packaging of another product.

Acetylcysteine Solution, USP (Roxane Laboratories, Inc.): Recall - Visible Glass Particle

02/03/2012 10:06 AM
Use of an inhaled product with glass particles has the potential to cause choking which could be life-threatening.

Lo/Ovral-28 (Norgestrel/EthinylEstradiol) Tablets: Recall - Possibility of Inexact Tablet Counts or Out of Sequence Tablets

02/01/2012 08:25 AM
Oral contraceptive daily regimen may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy.

Vitaflo USA Renastart: Recall - Possible Health Risk Due To Incorrectly Labeled Cans

01/31/2012 01:10 PM
Consequences of using the incorrectly labeled product may result in high potassium blood levels (hyperkalemia) or high sodium levels in the blood (hypernatremia).

Treanda (bendamustine HCL): Recall - Particulate Matter in Vial

01/30/2012 08:50 AM
Potential adverse events after intravenous administration of solutions containing particulates may include emboli and result in disruption of blood flow, causing tissue/organ damage.

Tysabri (natalizumab): Drug Safety Communication - New Risk Factor for Progressive Multifocal Leukoencephalopathy (PML)

01/20/2012 05:30 PM
The risks and benefits of continuing treatment with Tysabri should be carefully considered in patients who are found to be anti-JCV antibody positive and have one or more of the other known risk factors for PML.

Perfect Image Solutions Topical Hair Regrowth Products: Recall - Unapproved Drugs, Risk of Health Hazards

01/20/2012 02:55 PM
Systemic absorption of topically administered Minoxidil could cause low blood pressure, heart palpitations and associated cardiac symptoms.

Vagifresh Ball, Vagifresh Gel, Female One: Recall - Undeclared Drug Ingredient, Bacterial Contamination

01/20/2012 01:20 PM
Possibility of an adverse reaction or unknown drug-drug interaction.

Adcetris (brentuximab vedotin): Drug Safety Communication - Progressive Multifocal Leukoencephalopathy and Pulmonary Toxicity

01/13/2012 12:01 PM
New Boxed Warning and Contraindication highlighting these risks added to product labeling.

CardioGen-82 PET Scan: Drug Safety Communication - Increased Radiation Exposure

01/12/2012 03:15 PM
UPDATED 01/12/2012. FDA is updating healthcare professionals and the public about preliminary findings from ongoing investigations following the voluntary recall of CardioGen-82.

Respironics, Inc. Trilogy 100 Ventilators: Class I Recall - Device May Stop Delivering Therapy to Patient

01/12/2012 02:30 PM
Failure of therapy could result in the potential for harm or death of a ventilator-dependent patient.

Bedford Laboratories Polymyxin B For Injection USP And Vecuronium Bromide For Injection: Recall - Glass Particles

01/12/2012 12:58 PM
Particulate matter in injections can be harmful when introduced into the bloodstream.

Endo Pharmaceuticals Opiate Products by Novartis Consumer Health: Public Health Advisory - Potential Safety Risk

01/09/2012 10:40 AM
A packaging problem may result in a pill, tablet or caplet getting mixed in with a different prescription.

Novartis Consumer Health Over-The-Counter Products: Recall - Potential Presence of Foreign Tablets or Chipped or Broken Tablets or Gelcaps

01/09/2012 10:00 AM
Consumers are asked to either destroy or return unused product identified in the recall to Novartis.

Ikaria INOmax DS Drug Delivery System: Class I Recall - Erratic Nitric Oxide (NO) Readings

01/04/2012 03:18 PM
Adverse consequences may include hypoxia, hypotension, bradycardia, cardiac arrest, organ damage, acute respiratory distress syndrome (ARDS), neurological deficits, or death.

CareFusion AVEA Ventilator: Recall - Failure May Lead to Lack of Ventilation

12/23/2011 04:50 PM
Ventilator may stop ventilating and result in life-threatening injury or death.

Liquid Acetaminophen marketed for infants: Drug Safety Communication - Potential for Dosing Errors

12/22/2011 03:25 PM
Additional concentration of liquid acetaminophen marketed for “infants” (160 mg/5 mL) is now available.

Visit the US Food and Drug Administration Homepage