Meningitis vaccine, combination hepatitis C pill, and glucose meter for critically ill approved

Details on the latest recalls and approvals.


Recalls

A recall of certain lots of several Lifecare flexible intravenous solutions, including dextrose, sodium chloride, and lactated Ringers, due to potential for leakage. Inspection of a product lot identified a puncture going through the overwrap and primary container, which may result in leakage that is difficult to detect.

A recall of 10% neutral buffered formalin by Richard-Allan Scientific after defective products returned from several customers were found to have from 0% to 3% formalin content instead of the required 10%.

Photo from Thinkstock
Photo from Thinkstock.

A recall of 1 lot of 1% lidocaine HCI for injection by Hospira due to a confirmed customer report of particulate in a single unit, identified as a human hair embedded in and attached to a pinched area of the stopper.

A recall of 1 lot of vancomycin hydrochloride for injection by Hospira because the product may have experienced temperature excursions during shipment.

A recall of 2 lots of Intravia empty plastic containers by Baxter due to complaints of particulate matter found inside the fluid path.

A recall of 3 lots of ketorolac tromethamine injection, USP, 30 mg/ml, by Sagent Pharmaceuticals, due to labeling the product with the incorrect expiration date.

A recall of EnVe and ReVel ventilators by CareFusion due to potential for damage to their power cord adaptors which can cause loss of power and complete shutoff.

A recall of the ConMed Stat2 flow controller because it was assembled with the wrong internal component and may deliver fluid at a much higher flow rate than what is set.

A recall of GemStar power supplies for infusion pumps by Hospira because the power supply may not properly deliver electric power to the infusion pump.

A recall of all certain unexpired sterile products by Oregon Compounding Center due to lack of sterility assurance.

A field safety alert on Medi-Trace Cadence and Kendall multi-function defibrillation electrodes by Covidien because they will not connect with Philips FR3 or FRx AED units. The mismatch of these devices contributed to a delay in resuscitation in 2 cases and may have contributed to the subsequent death of 1 patient.

A recall of 1 lot of naproxen sodium tablets, sold under the brand name Assured, because some cartons contain bottles of ibuprofen.

A recall of the accessory strap for the Axilla application of the SAM Junctional Tourniquet, due to a potential issue with a clip used to secure the strap.

Approvals

A new indication for the Nova StatStrip Glucose Hospital Meter System, extending its use to critically ill patients who have been hospitalized. The meter was approved in April 2006 for use in hospitals as an aid in monitoring the effectiveness of a diabetes control program, but not for use with critically ill patients.

Combined ledipasvir and sofosbuvir (Harvoni) to treat chronic hepatitis C virus (HCV) genotype 1 infection. It is the first combination pill approved to treat HCV and the first approved regimen that does not require interferon or ribavirin. The combo is the third drug approved in the past year for HCV, after simeprevir (Olysio) in November 2013 and sofosbuvir (Sovaldi) in December 2013. Effectiveness is based on 3 trials of 1,518 patients, some treatment-naïve, others not, in which at least 94% achieved sustained virologic response. The most common side effects were fatigue and headache.

A vaccine (Trumenba) to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in patients 10 through 25 years. Previously, FDA-approved meningococcal vaccines only covered serogroups A, C, Y, and W. In 3 trials of 2,800 adolescents, 82% of those who got 3 doses had antibodies in their blood that killed 4 different serogroup B strains compared with less than 1% before vaccination. The most common side effects were pain and swelling at the injection site, headache, diarrhea, muscle pain, joint pain, fatigue, and chills.

The inFlow intraurethral valve-pump, a replaceable urinary prosthesis for women with impaired detrusor contractility (IDC). The device draws urine out to empty the bladder and blocks urine flow when continence is desired. A physician sizes the patient for the device and performs the initial insertion. After training, insertion and removal can be performed by the patient or a caregiver. In a trial of 273 women, over half stopped using the new device as a result of discomfort and leakage of urine, but 98% of those that continued had comparable post-void residual urine volume to that with clean intermittent catheterization. Adverse events associated with the device included asymptomatic bacteriuria, urinary tract infection, bladder inflammation, genitourinary pain, hematuria, urinary leakage, urinary frequency/urgency, bladder spasms, and vulvar, vaginal, and urethral disorders.