BiPAP machines, masks recalled

Recalls and alerts

A class I recall of certain bi-level positive airway pressure (BiPAP) machines by Philips Respironics due to a plastic issue that may expose patients to certain chemicals of concern. The recall includes 386 devices distributed from Aug. 6, 2020, to Sept. 1, 2021. This recall is unrelated to the foam issue impacting certain BiPAP machines recalled in June 2021. No associated adverse events have been reported.

A recall of certain masks used with BiPAP and continuous PAP machines by Philips Respironics due to a serious safety concern. The recalled masks have magnets and can cause potential injuries or death when use interferes with certain implanted metallic medical devices and metallic objects in the body of patients or others nearby. Fourteen serious injuries related to use of these masks have been reported. Five mask types are affected by the recall: the DreamWisp, DreamWear, Amara View, Wisp, and Wisp Youth masks.

A class I recall of the LifeSPARC Controller by LivaNova (TandemLife) due to a software malfunction. Two associated injuries have been reported. The recall includes 484 devices, which are part of the LifeSPARC System and were distributed since Dec. 19, 2019.

A class I recall of Clearlink Basic Solution Sets with Duovent by Baxter Healthcare Corporation due to increased customer reports of leaks that may expose clinicians and patients to hazardous substances. No associated adverse events have been reported. The recall includes 511,728 products distributed from Oct. 14, 2020, to June 30, 2022.

A recall of clopidogrel and atenolol by Golden State Medical Supply Inc. due to a label mix-up. The company recalled one lot of the products after receiving a report that a bottle containing clopidogrel tablets (75 mg) was mislabeled as containing atenolol tablets (25 mg). No associated adverse events have been reported.

A safety alert about reports of squamous-cell carcinoma and various lymphomas located in the capsule or scar tissue around breast implants. After an initial extensive review, the FDA currently believes that the risk of squamous-cell carcinoma and other lymphomas occurring in the tissue around breast implants is rare; however, the agency will soon complete a thorough literature review and will communicate findings to the public as it continues to learn more about reported cases.

An alert about potential clip lock malfunctions with MitraClip Clip Delivery Systems manufactured by Abbott. The company issued an urgent medical device correction after observing an increased rate of reports of clip lock malfunctions before and after deployment of the heart valve repair device. These events seem to occur in about 1.3% of MitraClip procedures and have been observed with all device models. The FDA will continue to monitor reports of associated adverse events.

An alert about a potential cybersecurity risk for the Medtronic MiniMed 600 Series Insulin Pump System. A potential issue associated with the communication protocol could allow unauthorized access to the pump system while the pump is being paired with other system components. Unauthorized access could compromise the pump's communication protocol, potentially causing the pump to deliver too much or too little insulin, the FDA said.

A recall of one lot of acyclovir sodium injection (500 mg per 10 mL [50 mg/mL] in single-dose vials) by Eugia US LLC (formerly AuroMedics Pharma LLC) due to particulate matter. A product complaint reported dark red, brown, and black particulate inside a vial. No associated adverse events have been reported. The lot was shipped to wholesalers nationwide from June 8 through June 13, 2022.

A recall of one lot of Antica Ocean Citron Hand Sanitizer (alcohol gel, 65%) by Salon Technologies International Inc. because lab testing found it contained benzene, a human carcinogen. No associated adverse events have been reported. The recall includes 512 bottles distributed in the Seattle area.

Miscellaneous

Steps to further increase monkeypox testing capacity and accessibility nationwide. The FDA issued guidance on enforcement policies, recommendations for emergency use authorization (EUA) requests for monkeypox diagnostic tests, and plans to prioritize review of EUA requests. The agency intends to update its recommendations as needed in response to the developing emergency. The FDA also issued the first EUA for a monkeypox in vitro diagnostic and the first EUA for a commercial test kit for the detection of monkeypox. The Quest Diagnostics Monkeypox Virus Qualitative Real-Time PCR and the Alinity m MPXV PCR test, respectively, are intended to detect monkeypox DNA using lesion swab specimens.

COVID-19 updates

A reissued letter of authorization for the Novavax COVID-19 Vaccine, Adjuvanted, to include myocarditis and pericarditis in the Vaccine Adverse Event Reporting System (VAERS) reporting requirements. Because some cases of myocarditis or pericarditis following vaccine administration may not meet the definition of serious adverse events, this change will help ensure that cases of myocarditis and pericarditis are reported to VAERS, the FDA said.

Approvals

Selpercatinib (Retevmo) for certain adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion. The drug, which received accelerated approval, is indicated in patients whose disease has progressed on or after prior systemic treatment or who have no satisfactory alternative treatment options. The most common adverse reactions in trials were edema, diarrhea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, and headache. The drug also received regular approval for adult patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) with an RET gene fusion, as detected by an FDA-approved companion diagnostic, the Oncomine Dx Target Test.

Marketing of the Phagenyx System, which delivers electrical stimulation to the oropharynx and is used as an aid in the treatment of stroke-related dysphagia.

First-time generic approvals

Empagliflozin tablets (10 mg and 25 mg) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. (Brand name: Jardiance)

Brexpiprazole tablets (0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg) as an adjunctive therapy to antidepressants for major depressive disorder in adults and to treat schizophrenia in adults. (Brand name: Rexulti)

Estradiol gel (0.1%) to treat moderate to severe vasomotor symptoms due to menopause. (Brand name: Divigel)

Sodium nitroprusside in 0.9% sodium chloride injection (10 mg/50 mL [0.2 mg/mL], 20 mg/100 mL [0.2 mg/mL], and 50 mg/100 mL [0.5 mg/mL]) in single-dose vials. (Brand name: Nipride RTU)

Rufinamide tablets USP, 100 mg, 200 mg, and 400 mg) for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in adults and in pediatric patients ages 1 year and older. (Brand name: Banzel)

Cetrorelix acetate for injection (0.25 mg/vial) in single-dose vials for the inhibition of premature luteinizing hormone surges in women undergoing controlled ovarian stimulation. (Brand name: Cetrotide)

Note: The FDA states that drugs are not always commercially available immediately after approval.