Healthcare Business

America's Unsafe Medical Products

Paul Ausick

Blood Pressure Medication Losartan May Be Tainted
> Issue Date: May 3, 2019
> Type of alert: Recall

Vivimed is recalling 19 lots of Losartan potassium tablets in 25mg, 50mg and 100mg dosages following detection of an impurity in the drug. The tablets were made in India and distributed in the United States by Heritage Pharmaceuticals.

Glass Fragment Found in Medication to Fight Against Organ Transplant Rejection
> Issue date: May 3, 2019
> Type of alert: Recall

Endo International’s Par Pharmaceuticals is voluntarily recalling one lot of its Mycophenolate Mofetil for Injection after one vial of the product was found to contain a fragment of glass. The drug is used for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.

New Box Warning on Some Insomnia Medicines
> Issue date: April 30, 2019
> Type of alert: Advisory

The FDA is advising patients, health care professionals and pharmacies of rare but serious injuries related to commonly used insomnia medicines such as Lunesta, Sonata, Ambien, Ambien CR, Edluar, Intermezzo and Zolpimist. Patients may exhibit such behaviors as sleepwalking or sleep driving while not fully awake. According to the FDA, complex sleep behaviors have led to serious injury or death.

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.

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.