America’s Unsafe Medical Products

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AmEx Pharmacy Recalls Macular Degeneration Drug
> Issue date: April 29, 2019
> Type of alert: Recall

One lot of Bevacizumab 1.25mg/0.05mL 31G injectable syringes are being recalled due to additional force necessary to inject the drug that could result in eye damage while the needle is in the eye. The drug is used to treat wet age-related macular degeneration and diabetic retinopathy. The lot number being recalled is 190212AB and had been distributed to ophthalmologist clinics in Pennsylvania, Illinois, Texas, Wisconsin, Kansas, Tennessee, Indiana and Arizona.

Teva Pharmaceuticals Recalls Losartan Tablets
> Issue date: April 29, 2019
> Type of alert: Recall

Teva Pharmaceuticals is voluntarily recalling six lots of 25 mg and 29 lots of 100 mg losartan tablets after detecting an impurity in the drugs manufactured by Hetero Labs. Losartan is used to treat hypertension.

Atrioseptostomy Dilatation Catheters Recalled
> Issue date: March 29, 2019
> Type of Alert: Recall

All catheters made by Edwards Lifesciences between December 22, 2017, and January 18, 2019, and distributed between January 8, 2018, and February 25, 2019, are being recalled because of possible difficulty in deflating the balloon, which could lead to balloon fragmentation or detachment when attempting to retrieve it. One serious injury to an infant was reported. This is a Class I recall, which means that continuing to use the devices may cause serious injury or death.

Using a Stent System Outside Approved Indications
> Issue date: April 25, 2019
> Type of alert: Safety communication

The FDA notified health care providers, patients with intracranial arterial sclerosis and institutional review boards about use of Stryker’s Wingspan Stent System, a device used approved only for patients between 22 and 80 years of age who meet a specific list of criteria. Using the device outside FDA-approved indications significantly raises the incidence of stroke or death within 72 hours.