America’s Unsafe Medical Products

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Lack of Sterility
> Issue date: June 18, 2019
> Type of alert: Recall

RXQ Compounding is recalling all sterile human and animal products due to lack of assurance that the products are sterile. The list of recalled products is available in an FDA announcement.

Lack of Sterility
> Issue date: June 18, 2019
> Type of alert: Recall

Premier Pharmacy Labs is voluntarily recalling all unexpired products due to a lack of sterility assurance. A list of the recalled products is available in an FDA announcement.

Hospital Infant Warmers May Break
> Issue date: June 18, 2019
> Type of alert: Recall

GE Healthcare is recalling its Giraffe Warmers and Panda iRes Warmers used by hospitals and clinicians to care for infants. The company has notified its hospital customers and will replace all cracked or damaged panels and latches on the warmers at no cost.

Balloon Catheters Bursting Below Rated Burst Pressure
> Issue date: June 18, 2019
> Type of alert: Recall

Cook has voluntarily recalled its Advance Enforcer 35 Focal-Force PTA Balloon Catheter used by health care providers to open blocked or narrowed arteries that supply blood to the leg. In the United States, 33 of the devices have been recalled.

Serious Adverse Reaction in Fecal Microbiota Transplantation
> Issue date: June 18, 2019
> Type of alert: Safety communication

Two adults with weakened immune systems who received investigational fecal microbiota for transplantation (FMT) developed invasive infections caused by E. coli present in the donor stool. One of the patients died. The FDA has instituted new protections for further use of investigational FMT and requires all investigational new drug (IND) holders to implement these requirements by July 15. More details are included in an FDA announcement.

Impurity Found in Losartan Tablets
> Issue date: June 11, 2019
> Type of alert: Recall

Teva Pharmaceuticals USA is recalling two lots of 50 mg and four lots of 100 mg Losartan potassium tablets manufactured by Hero Labs after detecting an impurity in the medicine. This recall is a follow on to an April recall for a similar reason.

Findings in FDA Investigation Into Compounding Sterile Drugs
> Issue date: June 10, 2019
> Type of alert: Report

Following reports received earlier this year regarding the use of glutathione L-reduced powder (L-glutathione) distributed by Letco Medical to compound sterile injectable drugs, the FDA initiated an investigation into the adverse events. These results bore out the initial observation that compounders were using an ingredient meant to be used for dietary supplements to compound sterile injectable drugs. Additional details are available in the FDA announcement.

Faulty Software in Ventilator
> Issue date: June 3, 2019
> Type of alert: Recall

The Hamilton-G5 ventilator sporadically displays an error message that communication between the device and its control panel has been lost and then sounds an alarm before turning itself off. The manufacturer has a new software version that reduces the probability of such an event.