Healthcare Economy

America's Unsafe Medical Products

Paul Ausick

Legacy Pharmaceutical Packaging Recall
> Issue date: April 24, 2019
> Type of alert: Recall

Legacy Pharmaceutical Packaging is expanding its recall of three lots of 50 mg Losartan tablets to include a fourth lot related to a recall of the tablets by Torrent Pharmaceuticals due to the detection of a contaminant in the tablets.

Alvogen Recalls Fentanyl Transdermal Patch System
> Issue date: April 19, 2019
> Type of alert: Recall

Alvogen is voluntarily recalling two lots (180060 and 180073) of its 12 mcg/h fentanyl transdermal patch system with an expiration date of May and June 2020. Some of the cartons contain 50 mcg/h doses. According to the FDA, using the higher dosage patch “could result in serious, life threatening, or fatal respiratory depression.”

Torrent Pharmaceuticals Recalls More Losartan Tablets
> Issue date: April 18, 2019
> Type of alert: Recall

Torrent Pharmaceuticals has expanded its recall of 50 mg Losartan tablets to include 36 lots of Losartan potassium tablets and 68 lots of Losartan potassium/hydrochlorothiazide tablets due to possible contamination.

Brainlab Recalls Surgical Navigation Software
> Issue date: April 15, 2019
> Type of alert: Recall

Brainlab is recalling its Brainlab Spine & Trauma 3D Navigation software used in its systems to help surgeons safely navigate surgical tools and implants used before and during minimally invasive surgical procedures. The recall covers 60 systems sold in the United States. The FDA classifies this as a Class I recall, which means that using the devices may cause serious injury or death.

Endo-Surgery Staplers Recalled
> Issue date: April 11, 2019
> Type of alert: Recall

Endo-surgery curved intraluminal staplers and endoscopic curved intraluminal staplers made by Ethicon have been recalled due to a flawed firing mechanism that can compromise the integrity of the staples. This is a Class I recall meaning that using the devices may cause injury or death. More than 92,000 of the devices have been recalled in the United States. More details are available at the FDA website.

Addyi (Flibanserin) Labeling Change
> Issue date: April 11, 2019
> Type of alert: Safety communication

Addyi from Sprout Pharmaceuticals is known as the female Viagra. The FDA has determined that the product’s labeling must be changed to reflect continuing concerns about the consumption of alcohol near in time to taking Addyi. The boxed warning, contraindication, warnings and precautions and adverse reactions sections of labeling are being updated to reflect that women should discontinue drinking alcohol at least two hours before taking Addyi at bedtime or to skip the Addyi dose that evening.

Medical Devices Used to Test for and Diagnose Head Injuries
> Issue date: April 10, 2019
> Type of alert: Safety communications

FDA-approved devices used to assess, diagnose or manage head injuries such as concussion, traumatic brain injury and mild traumatic brain injury do not yet include any devices that may be used without an evaluation by a health care provider. Unapproved devices include smartphone or tablet-based apps that are said to be capable of determining changes in mental/cognitive status, including changes to vision, concentration, memory, balance and speech.