Lynn Peavey, a manufacturer of sexual assault evidence and blood alcohol collection kits, has received a GMP warning for several issues, such as lack of procedures for incoming product inspections and lack of verification activities.
U.S. devicemakers may have difficulty obtaining a virus strain that the FDA suggests using to conduct reactivity tests for new products to detect Clostridium difficile infections.
Topamax (topiramate): Label Change - Risk For Development of Cleft Lip and/or Cleft Palate in NewbornsMarch 4, 2011 7:30 am | by U.S. Food & Drug Administration | News | Comments
Increased risk of oral clefts in infants born to women treated with Topamax (topiramate) during pregnancy.
Endotoxins in product can cause serious illness, at times fatal.
Reason for Recall: Testing cannot confirm that all units of XenMatrix Surgical Graft are within FDA requirements for endotoxin levels. Several lots have been found to have elevated endotoxin levels. Endotoxins (pyrogens) are substances found in certain...
Cook Inc., Single, Double, Triple and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripheral Inserted Central Venous Catheter Trays: Class I Reca...March 3, 2011 12:31 pm | by U.S. Food & Drug Administration | News | Comments
Leakage and possible loss of sterility, which may lead to serious adverse health consequences and/or death.
Class I Medical Device Recall: Cook Inc., Single, Double, Triple and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripheral Inserted Central Veno...March 3, 2011 10:30 am | by U.S. Food & Drug Administration | News | Comments
These kits and trays contain 0.9% Sodium Chloride Injection USP 5 mL fill in 6 mL flush syringes that have been recalled by Excelsior Medical. Leaks in the plunger luer were detected during a routine syringe leak test. The potential exists for leakage...
Unapproved products have not been evaluated by the FDA for safety, effectiveness, and quality.
Proton Pump Inhibitor drugs (PPIs): Drug Safety Communication - Low Magnesium Levels Can Be Associated With Long-Term UseMarch 2, 2011 5:30 am | by U.S. Food & Drug Administration | News | Comments
Prolonged treatment with prescription PPIs may lead to low serum magnesium levels, which can result in serious adverse events including muscle spasm (tetany), irregular heartbeat (arrhythmias), and convulsions (seizures).
FDA meta-analysis of clinical trials did not show an increased risk of MI associated with the use of abacavir.
UPDATED 02/28/2011. Reports of deaths and serious complications, especially bleeding and infection, associated with NPWT.
Product marketed as a dietary supplement contains sibutramine, which may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
With the European Parliament’s consent for enhanced cooperation, a common EU patent system may become a reality.
Medtronic is eliminating up to 2,000 positions during the third quarter as part of a major restructuring it blames on softer markets.
The Revo MRI SureScan Pacing System is designed to deliver standard pacing therapy in patients who have slow heart rates (bradycardia). Unlike most other pacing systems, the Revo MRI SureScan Pacing System has been specifically designed and tested to...
Labeling, Approval Order, and Summary of Safety and Effectiveness for Revo MRI SureScan Pacing System (P090013).
Counterfeit dietary supplement contains tadalafil, sildenafil, and/or sibutramine, which may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
FDA received a report about a brown area on the lens cover of an infant phototherapy light. Upon closer examination, the lens cover also had burned and melted areas from having been improperly positioned under the heating element of an infant warmer...
Antipsychotic drugs: Class Labeling Change - Treatment During Pregnancy and Potential Risk to NewbornsFebruary 22, 2011 6:32 am | by U.S. Food & Drug Administration | News | Comments
Risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs.
The FDA has down-classified medical device data systems (MDDS) from Class III into Class I via a final rule, which could help manufacturers compete with IT companies in this area.
Quality problems with metal-on-metal (MoM) hip replacement systems, like Johnson & Johnson (J&J)’s ASR devices, may not be as widespread as UK data indicates, the FDA says.
Potential for serious maternal heart problems and death.
Recall due to pocket fills may result in patient harm, serious injury, and/or death due to drug overdose or underdose.
These test strips may give falsely low glucose results. False results may lead patients or health care providers to try to raise their blood glucose unnecessarily, or they may fail to treat elevated blood glucose because of a false, low reading...
Reason for Recall: This product may not be sterile. Patients, who are immuno-compromised, such as those with diabetes, cancer and certain other chronic diseases, may be at potential risk for infection.