America’s Unsafe Medical Products

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Nicotine-Laced Candy Contains Too Much of the Drug
> Issue date:
May 31, 2019
> Type of alert: Recall

Drip More recalled four lots of its Candy King-Worms 3mg/100mL that contain more nicotine than indicated on the label. Approximately 7,105 units of the product were shipped to 26 states. The FDA notes that accidental nicotine exposure in children may be harmful or fatal.

Mislabeled Children’s Cough Syrup
> Issue date: May 29, 2019
> Type of alert: Recall

Novis PR is voluntarily recalling five lots of Pecgen DMX, that contains incorrect dosage information on the label. The product was sold only in Puerto Rico.

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.