America’s Unsafe Medical Products

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The U.S. Food and Drug Administration (FDA) has issued eight new safety alerts, comprising six related to product recalls, including one for an animal antibiotic; one regarding mortality rate among users of a support device for heart transplant patients; and one for a device that may give inaccurate results on diagnostic tests.

The FDA issues safety alerts to provide timely new safety information on human drugs, medical devices, vaccines and other products including biologics, dietary supplements and cosmetics. The alerts are publicly available at the agency’s MedWatch website and contain “actionable information that may impact both treatment and diagnostic choices for healthcare professional and patient.”

The following list includes all MedWatch alerts for 2019 through May 28. There are several types of alerts, including letters to health care providers, warnings to users, drug safety notices and recalls. The 2019 alerts are listed in reverse chronological order, so the most recent are listed first. Included are the type of alert and the issue date.

Failed Sterility Test
> Issue date: May 28, 2019
> Type of alert: Recall

Heritage Pharmaceuticals initiated a voluntary recall of two products — Amikacin Sulfate Injection, USP, 1g/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL) — after unreleased lots were found to have microbial growths.

Veterinary Injectable Drug Product Sterility May Be Compromised
> Issue date: May 24, 2019
> Type of alert: Recall

U.K.-based Norbrook Laboratories is recalling 34 lots of injectable drug products, including a product used to treat and control bovine respiratory disease and swine respiratory disease, as well as controlling Colibacillosis in swine. The full list of recalled products is available in the FDA’s alert.

Sterile Compounded Drug Products Recalled
> Issue date: May 24, 2019
> Type of alert: Recall

Houston-based Pharm D Solutions is voluntarily recalling all sterile compounded drug products as a result of a routine FDA inspection that found practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile.

Cranial Drainage Devices May Break
> Issue date:
May 24, 2019
> Type of alert: Recall

Integra LifeSciences is recalling its LimiTorr and MoniTorr cranial drainage systems due to reported complaints of breakage. Serious patient injuries were reported, but no deaths. The recall covers 24,587 devices distributed throughout the United States.

Blood Pressure Monitor May Catch Fire
> Issue date: May 24, 2019
> Type of alert: Recall

Edwards Lifesciences is recalling 11,000 EV1000A, EV1000NI, EV1000CS EV100 Clinical Platforms used to monitor a patient’s blood pressure and pulse during and after surgery. If used improperly, the devices could short circuit and cause a fire.

Clearance of Endoscope Port Connector
> Issue date: May 23, 2019
> Type of alert: Clearance letter

The FDA has cleared a modified Erbe USA ERBEFLO connector that reduces the risk of backflow and contamination of the irrigation system. In April 2018, the FDA found that the device did not adequately mitigate the risks of cross-contamination.