Recalls, warnings, and alerts
A class I recall of the HawkOne Directional Atherectomy System by Medtronic Inc. due to the risk of catheter tip damage during use. There have been 163 complaints, 55 injuries, and no deaths related to this issue. The recall includes 95,110 devices distributed from Jan. 22, 2018, to Oct. 4, 2021.
A class I recall of the Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump by Getinge/Datascope/Maquet due to reports of fluid leaks. There have been 71 complaints and one death related to this issue. The recall includes 4,338 devices distributed from March 6, 2012, to Oct. 21, 2021.
A class I recall of the Puritan Bennett 980 Series Ventilator by Covidien LP (part of Medtronic) due to a manufacturing assembly error that may cause the ventilator to become inoperable or stop working as intended. There have been six complaints and one death related to this issue. The recall includes 135 devices distributed from Feb. 23, 2017, to April 4, 2020.
A class I recall of the Vaporizer Sevoflurane Maquet filling for Flow Family Anesthesia Systems by Getinge USA Sales LLC due to a risk of harmful chemical exposure. There have been eight complaints and no reported deaths or injuries related to this issue. The recall includes 50 devices distributed from Feb. 16 to Oct. 30, 2021.
A class I recall of the Synergy Cranial and StealthStation S7 Cranial Software by Medtronic due to a potential risk of inaccuracies caused by the biopsy depth gauge cycle view. There have been four complaints and no reported injuries or deaths regarding this device issue. The recall includes 943 devices distributed on Nov. 11, 2021.
A class I recall of the WIRION Embolic Protection Device by Cardiovascular Systems Inc. due to filter breakage during retrieval. There have been nine reports of device malfunction and no reports of death related to this issue. The recall includes 697 devices distributed from March 22 to Nov. 15, 2021.
A recall of one batch of insulin glargine injection (Semglee; 100 units/mL in 3-Ml prefilled pens) by Mylan Pharmaceutical Inc. due to the potential for a missing label in the batch. No related adverse events have been reported. The recalled lot was distributed in the U.S. between May 11 and Nov. 11, 2021.
A recall of 23 additional lots of metformin hydrochloride extended-release tablets USP (750 mg) by Viona Pharmaceuticals Inc. due to excess levels of N-nitrosodimethylamine, a probable human carcinogen. The company had previously recalled 33 lots of the medication. Recalled products were manufactured by Cadila Healthcare Limited in India and were shipped to U.S. distributors. No related adverse events have been reported.
A recall of 14 lots of the Destino Twist Steerable Guiding Sheath by Oscor Inc. due to an increased risk of the hub cap and seal on the proximal end of the device handle detaching during use. There have been two medical device reports related to this issue. Affected devices, the Destino Twist 14F model DST1405525 and Guidestar 14F model D141103, were distributed worldwide to distributors and hospitals from June 8 to Nov. 30, 2021.
A recall of one lot of polymyxin B for injection USP (500,000 units/vial) by AuroMedics Pharma LLC due to the presence of particulate matter. Hair was discovered in a vial within this lot. No related adverse events or identifiable safety concerns were reported. Recalled products were distributed to wholesalers nationwide from March 19 through June 14, 2021.
A warning to patients and prescribers about the potential for dental problems associated with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain. The FDA is requiring a warning about this risk to be added to the prescribing information and the patient medication guide for all buprenorphine-containing medicines dissolved in the mouth. While the FDA cannot determine how likely it is that a patient will experience dental problems when taking such medications, the benefits for opioid use disorder and pain clearly outweigh the risks, the agency said. Patients should notify their clinicians immediately and seek dental care should they experience any issues with their teeth or gums while taking these medications.
A recall of one lot of senna syrup (8.8 mg in 5-mL unit-dose cups) by Lohxa LLC due to potential microbial contamination. Recalled products were distributed to wholesaler AvKare, which may have further distributed them to clinics, hospitals, and clinicians. To date, the company has not received any reports of related adverse events.
A recall of one lot of RevitaDerm Wound Care by Blaine Labs due to potential bacterial contamination. One 1-oz bottle was found to be contaminated with Bacillus cereus. Recalled products were distributed to 61 physician clinics in 17 states in the U.S. in 2021. To date, the company has not received any reports of related adverse events.
A recall of one lot of clobetasol propionate ointment USP (0.05% in 60-g tubes) by Taro Pharmaceuticals due to microbial contamination. The manufacturer discovered the presence of Ralstonia pickettii bacteria through routine testing. Recalled products were distributed to two wholesale distributors in the U.S. between Nov. 16 and Dec. 6, 2021. To date, the company has not received any reports of related adverse events.
A recall of three lots of nitroglycerin lingual spray (12 g) by Padagis US LLC due to a complaint that a unit may not dispense. Recalled products were distributed nationwide to wholesalers and retailers. To date, the company has not received any reports of related adverse events.
A cybersecurity alert on the Fresenius Kabi Agilia Connect Infusion System. Successful remote exploitation of these vulnerabilities could allow an attacker to gain access to sensitive information, to modify settings, or to perform arbitrary actions as an unauthorized user. Several affected components require a software security patch to address these vulnerabilities. In addition, the company has determined that about 1,200 infusion pumps would need hardware changes.
Emergency use authorizations (EUAs) for two oral antiviral treatments for mild to moderate COVID-19. Nirmatrelvir and ritonavir (Paxlovid), copackaged for oral use, is indicated for adults and children 12 years of age and older who weigh at least 40 kg, have a positive SARS-CoV-2 test result, and are at high risk for severe COVID-19. Molnupiravir (available as Lagevrio in certain markets outside of the U.S.) is indicated for adults with a positive viral test result who are at high risk for progression to severe disease and for whom other treatment options are unavailable or clinically inappropriate. Both drugs should be administered as soon as possible after COVID-19 is diagnosed and within five days of symptom onset.
Expanded use of remdesivir to treat certain nonhospitalized patients with mild to moderate COVID-19 disease. Previously, the use of remdesivir (Veklury) was limited to patients requiring hospitalization. The FDA expanded the drug's approved indication to include its use in patients ages 12 years or older weighing at least 40 kg with positive results on direct SARS-CoV-2 viral testing who have mild to moderate COVID-19 and are not hospitalized and are at high risk for progression to severe COVID-19, including hospitalization or death. These high-risk outpatients may receive the drug via IV infusion for a total of three days for the treatment of mild to moderate COVID-19.
Approval of the second mRNA COVID-19 vaccine. The vaccine, which has been known as the Moderna COVID-19 vaccine, is now marketed as Spikevax for the prevention of COVID-19 in individuals ages 18 years and older. The FDA based its approval decision on updated data from a randomized controlled trial of thousands of participants showing that the vaccine was 93% effective in preventing COVID-19 and 98% effective in preventing severe disease. These data were accrued before the omicron variant emerged. More than half of participants were followed for safety outcomes for at least four months after the second dose, and about 7,500 were followed for at least six months. The FDA reviewed postauthorization safety surveillance data pertaining to myocarditis and pericarditis and determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is highest among men ages 18 through 24 years, the agency said. The prescribing information includes a warning about these risks. The vaccine continues to be available under EUA.
Updated EUAs for the Pfizer-BioNTech and Moderna COVID-19 vaccines. The updated EUAs shortened the time between the completion of a primary series of the vaccine and a booster dose to at least five months for adults.
An updated EUA for COVID-19 convalescent plasma. The update limits the authorization to the use of COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies for the treatment of COVID-19 in patients with immunosuppressive disease or those who are receiving immunosuppressive treatment. These patients may be treated in outpatient or inpatient settings.
A warning not to use the CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test by Empowered Diagnostics due to a potentially higher risk of false results. These tests were distributed with labeling indicating they are authorized by the FDA, but neither test has been authorized, cleared, or approved by the FDA for distribution or use in the U.S. The company is recalling the tests, and the FDA has identified this as a class I recall, the most serious type.
A warning not to use the COVID-19 Antigen Test and COVID-19 IgG/IgM Antibody Test by LuSys Laboratories due to a high risk of false results. Neither test has been authorized, cleared, or approved by the FDA for distribution or use in the U.S. The tests may also be sold under the company names Luscient Diagnostics or Vivera Pharmaceuticals, or with the trade name EagleDx.
Abbreviated new drug applications for certain drugs that have seen increased demand during the COVID-19 public health emergency. These medications include methylprednisolone acetate injectable suspension USP (200 mg/5 mL [40 mg/mL], 400 mg/10 mL [40 mg/mL], and 400 mg/5 mL [80 mg/mL]).
Marketing of the first cigarettes to help reduce exposure to and consumption of nicotine for smokers who use them. 22nd Century Group Inc.'s VLN King and VLN Menthol King are the first combusted cigarettes to be authorized as modified-risk tobacco products and the second tobacco products overall to receive “exposure modification” orders, which allows them to be marketed as presenting a reduced exposure to a substance. Authorized claims include “95% less nicotine” and “Helps reduce your nicotine consumption.” When using any reduced-exposure claims in the product label or advertising, the company must include, “Helps you smoke less,” as well as one of four warning statements for cigarettes as required by law.
First-time generic approvals
Valsartan oral solution (20 mg/5 mL [4 mg/mL]) for the treatment of hypertension and heart failure and to reduce risk of cardiovascular death in patients who are unable to swallow valsartan tablets after myocardial infarction. (Brand name: Prexxartan)
Ivabradine tablets (5 mg and 7.5 mg) to reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction. (Brand name: Corlanor)
Vasopressin injection USP (20 units/mL in multiple-dose vials) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. (Brand name: Vasostrict)
Mivacurium chloride injection (10 mg/5 mL [2 mg/mL] and 20 mg/10 mL [2 mg/mL] in single-dose vials) for inpatients and outpatients as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. (Brand name: Mivacron)
Lubiprostone capsules (8 µg and 24 µg) for the treatment of opioid-induced constipation in adult patients with chronic, noncancer pain, including those with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. (Brand name: Amitiza)
Betaine anhydrous for oral solution (180 g/bottle) for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations. (Brand name: Cystadane)
Amphotericin B liposome for injection (50 mg/vial in single-dose vials) for empirical therapy of presumed fungal infection in febrile, neutropenic patients and for the treatment of cryptococcal meningitis in HIV-infected patients; of patients with Aspergillus species, Candida species, and/or Cryptococcus; and of those with visceral leishmaniasis. (Brand name: AmBisome)
Timolol maleate ophthalmic solution USP (0.25% [base] and 0.5% [base] in single-dose vials) to treat elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. (Brand name: Timoptic)
Glycerol phenylbutyrate oral liquid (1.1 g/mL) for the chronic management of patients ages 2 years and older with urea cycle disorders who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. (Brand name: Ravicti)
Nelarabine injection (250 mg/50 mL [5 mg/mL] in single-dose vials) to treat patients with T-cell acute lymphoblastic leukemia and those ages 1 year and older with T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. (Brand name: Arranon)
Dasatinib tablets (80 mg and 140 mg) to treat newly diagnosed adults with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase; adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib; and adults with Ph+ acute lymphoblastic leukemia with resistance or intolerance to prior therapy. (Brand name: Sprycel)
Note: The FDA states that drugs are not always commercially available immediately after approval.