Legal Settlements and Updates from North Carolina and across the United States

Helping you keep up-to-date on issues that may affect your claim

FDA Alert – Acrodose PLus and PL Systems by Haemonetics

ISSUE: Haemonetics recently received reports of low pH readings for platelets stored in the CLX HP bag in certain lots of the Acrodose PLus and PL systems. In some instances the drop in pH is accompanied by a yellow discoloration of the storage bag. Platelets with pH...
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FDA Alert – Coastal Meds Recall of All Products Marketed as Sterile

ISSUE: FDA is alerting health care professionals to a voluntary recall of all non-expired products marketed as sterile made by Coastal Meds due to visible particles in some of the drug vials for injection. BACKGROUND: During FDA’s recent inspection of Coastal Meds,...
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Acyclovir 400mg Tablets by Apace Packaging: Recall – Product Mix-up

Apace Packaging LLC is voluntarily recalling one lot of Acyclovir Tablet, USP, 400mg, 50ct Unit Dose, NDC# 50268-061-15, Lot Number 19900, to the retail level. These products have been recalled due to a product mix-up. A small number of blister cards containing Acyclovir Tablets, 400mg, UD Blister Cards may potentially also include Torsemide, 20mg Tablets.

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Clarithromycin (Biaxin): Drug Safety Communication – Potential Increased Risk of Heart Problems or Death in Patients With Heart Disease

FDA is advising caution before prescribing the antibiotic clarithromycin (Biaxin) to patients with heart disease because of a potential increased risk of heart problems or death that can occur years later. FDAs recommendation is based on a review of the results of a 10-year follow-up study of patients with coronary heart disease from a large clinical trial that first observed this safety issue.

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Labetalol Hydrochloride Injection by Hospira: Recall – Potential For Cracked Glass At Rim Surface Of Vials

ISSUE: Hospira is voluntarily recalling 3 lots of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL Vial (NDC 0409-2267-20), and one lot of Labetalol Hydrochloride Injection, USP, Novaplus (NDC 0409-2267-25) to the hospital/institution level. Hospira, Inc....
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Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs) by Medtronic: Class I Recall- Manufacturing Error

Medtronic is recalling certain ICDs and CRT-Ds due to a defect in the manufacturing process. This defect causes an out of specification gas mixture inside the device and may prevent the device from delivering the electrical shock needed to pace a patient’s heartbeat or revive a patient in cardiac arrest. The delay or inability to deliver a shock to a patient in cardiac arrest or pace a patient’s heart whose heartbeat is too slow could result in serious injury and/or death.

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204 E. Arlington Blvd.

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Greenville, NC 27858

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