Recalls, warnings, and alerts
A class I recall of Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps by Getinge/Datascope/Maquet due to complaints of fluid leaks. There have been 71 complaints and one death reported for this issue. The recall includes 4,338 devices distributed from March 6, 2012, to Oct. 21, 2021.
A class I recall of the Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7FR by Teleflex Incorporated due to potential detachment of the inner lumen from the device's basket. Seven customer complaints have been reported for this issue. In one complaint, the clinician used a snare to retrieve the detached lumen from the patient. No long-term patient complications have been reported. The recall includes devices manufactured from October 2019 through July 2021.
A class I recall of all ultrasound gels and lotions by Eco-Med due to risk of bacterial contamination with Burkholderia cepacia complex. There have been at least 66 infections, including 60 bloodstream infections, associated with the affected products, according to the CDC. Recalled products were distributed since 2018, although the company has since shut down all operations.
A recall of all lots of sterile and nonsterile drugs compounded at Edge Pharma LLC due to process issues that could lead to a lack of sterility and/or quality assurance. No related adverse events have been reported. Recalled products were distributed nationwide and directly to customers and medical facilities.
A recall of one lot of enoxaparin sodium injection USP (40 mg/0.4 mL) by Sandoz Inc. due to exposure to higher temperatures, which may have impacted product effectiveness. There have been no reports of related adverse events or injuries. Recalled products were distributed nationwide to wholesalers and retailers.
A recall of four lots of levetiracetam injection USP (500 mg per 5 mL) by Sagent Pharmaceuticals Inc. due to lack of sterility assurance. There have been no related complaints or adverse events. Recalled products were distributed nationwide from March to November 2021.
A recall of two lots of lidocaine hydrochloride topical solution USP 4% by Teligent Pharma Inc. due to superpotency. Company testing found the recalled products to be superpotent based on out-of-specification results obtained at nine- and 18-month stability timepoints. No related adverse events have been reported. Affected products were distributed at the wholesale and retail levels nationwide.
An alert raising awareness about a cybersecurity vulnerability in Apache's Log4j software library (versions 2.0-beta9 to 2.14.1.). The software is broadly used to log security and performance information in a variety of consumer and enterprise services, websites, and applications, as well as medical devices and supporting systems. While cybersecurity vulnerabilities may introduce risks for certain medical devices, there have been no confirmed reports of related adverse events, the FDA said.
A recall of two lots of liquid probiotics by Liva Global Inc. due to bacterial contamination with Pseudomonas aeruginosa. There have been no direct complaints from consumers. Recalled products were distributed nationwide through Amazon, wholesale, and direct sales from the company's website.
Recalls of several consumer products by Procter & Gamble due to the presence of benzene, a human carcinogen. These recalls include aerosol spray products, such as dry shampoo and antiperspirants, from brands including Old Spice, Secret, Pantene, Aussie, and Herbal Essences.
A recall of about 240 lots of products intended to be sterile by SterRx LLC due to a lack of sterility assurance. Recalled products, which include fentanyl, morphine, midazolam, and others, were distributed to hospitals nationwide from December 2020 to October 2021.
A recall of all batches of irbesartan tablets (75 mg, 150 mg, and 300 mg) and irbesartan and hydrochlorothiazide tablets (150 mg/12.5 mg and 300 mg/12.5 mg) by Lupin Pharmaceuticals Inc. due to the potential presence of N-nitrosoirbesartan, a probable human carcinogen. The manufacturer received four reports of illness from irbesartan and no reports from irbesartan and hydrochlorothiazide from Oct. 8, 2018, to Sept. 30, 2021. The company discontinued marketing the products on Jan. 7, 2021.
A recall of one lot of vancomycin hydrochloride for oral solution (Firvanq) by Azurity Pharmaceuticals Inc. due to a mix-up of the diluent included in the kit. Some products in the recalled lot were found to incorrectly contain a FIRST-Omeprazole diluent instead of the Firvanq diluent bottle. Recalled products were distributed nationwide through wholesale distributors. No related adverse events have been reported.
A recall of one lot of daptomycin for injection (CUBICIN) by Merck due to particulate matter identified as glass. No related adverse events have been reported. About 22,000 recalled vials were distributed to wholesalers between June 1 and Sept. 9, 2021.
A recall of one lot of glucagon for injection (Glucagon Emergency Kit for Low Blood Sugar) by Eli Lilly and Company due to loss of potency. A product complaint reported that the vial of glucagon in the kit was in liquid form instead of powder form and that the involved patient experienced lack of drug effect and reported subsequent seizures. The liquid form of this product could fail to treat severe hypoglycemia due to loss of potency, the FDA said. A company investigation determined that the liquid in the vial could be related to the manufacturing process. The affected product lot was distributed to wholesalers and retailers nationwide.
A recall of one lot of methocarbamol tablets by Bryant Ranch Prepack because bottles labeled as containing 500 mg of the drug contained 750 mg. Recalled products were distributed nationwide to multiple physician offices.
Authorization of enforcement discretion to temporarily ease certain requirements in the Clozapine Risk Evaluation and Mitigation Strategy (REMS). Implementation of a modification to the REMS on Nov. 15, 2021, resulted in high call volumes and long wait times at the REMS Contact Center, creating access issues for some patients. To ease these problems, the FDA temporarily stopped enforcing requirements around wholesaler shipping and pharmacy dispensing of clozapine. Patients should continue to have their absolute neutrophil count monitored, the agency said.
A recall of two lots of remdesivir, 100 mg for injection (Veklury), by Gilead Sciences Inc. due to the presence of glass particulates. One customer complaint of the presence of glass particulates was confirmed by a company investigation. Affected lots were distributed nationwide beginning October 2021.
A letter to clinicians and clinical laboratory staff about false-positive test results on rapid plasma reagin (RPR) when using the Bio-Rad Laboratories BioPlex 2200 Syphilis Total & RPR kit in some people who received a COVID-19 vaccine. While RPR false reactivity was observed in some individuals for at least five months following a COVID-19 vaccination, the FDA noted that COVID-19 vaccines do not cause syphilis. Clinicians should continue to strongly encourage patients to get vaccinated against COVID-19 and should be aware of their patients' vaccination status when interpreting reactive RPR test results, which should always be confirmed with treponemal testing (e.g., Treponema pallidum particle agglutination), according to the agency.
A recommendation not to use certain SARS-CoV-2 tests due to their inability to detect the omicron variant. These tests include the Revogene SARS-CoV-2 test by Meridian Bioscience Inc., the DTPM COVID-19 RT-PCR test by Tide Laboratories LLC, and the Linea COVID-19 Assay Kit by Applied DNA Sciences.
An emergency use authorization for tixagevimab co-packaged with cilgavimab and administered together (Evusheld) for the pre-exposure prophylaxis of COVID-19. The long-acting monoclonal antibodies are authorized for this indication in patients ages 12 years and older weighing at least 40 kg. The drug combination is only authorized for individuals who are not currently infected with the SARS-CoV-2 virus and who have not recently been exposed to an individual with the virus. The authorization also requires that individuals have moderately to severely compromised immune systems due to a medical condition or due to taking immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccines, or have a history of severe adverse reactions to a COVID-19 vaccine and/or its components.
Revisions to the Johnson & Johnson (Janssen) COVID-19 vaccine fact sheets for vaccination providers and recipients/caregivers. The fact sheets now include a contraindication for the administration of the vaccine to individuals with a history of thrombosis with thrombocytopenia following the Janssen COVID-19 vaccine or any other adenovirus-vectored COVID-19 vaccine. Cases of thrombosis with thrombocytopenia syndrome following vaccination have been reported in adults, with the highest reporting rate at about one case per 100,000 doses administered in women ages 30 to 49 years; overall, about one out of seven cases has been fatal. The FDA continues to find that the known benefits of the vaccine outweigh its known and potential risks in adults.
Abbreviated new drug applications for certain drugs that have seen increased demand during the COVID-19 public health emergency, including vasopressin injection (20 units/mL in multiple-dose vials) and vancomycin hydrochloride for injection.
Maribavir (Livtencity) as the first drug to treat certain patients with post-transplant cytomegalovirus (CMV) infection that does not respond to available antiviral treatment. The drug, which is indicated for patients ages 12 years and older weighing at least 35 kg, works by preventing the activity of human CMV enzyme pUL97, blocking virus replication. In one study, 352 transplant recipients with CMV infection who did not respond to treatment (with or without genetic mutations that cause resistance) randomly received the drug or a treatment assigned by a researcher for up to eight weeks. Of the 235 patients who received maribavir, 56% had levels of CMV DNA below what was measurable versus 24% of the 117 patients who received a different treatment. The most common side effects of the drug include taste disturbance, nausea, diarrhea, vomiting, and fatigue. It may also reduce the antiviral activity of ganciclovir and valganciclovir, so coadministration with these drugs is not recommended. As virologic failure due to resistance can occur during and after treatment, clinicians should monitor CMV DNA levels and assess for drug resistance if a patient is not responding to treatment or relapses.
First generic drug approvals
Brimonidine topical gel (0.33%) for the topical treatment of persistent facial erythema associated with rosacea in adult patients. (Brand name: Mirvaso)
Oxymetazoline hydrochloride cream (1%) for the topical treatment of persistent facial erythema associated with rosacea in adult patients. (Brand name: Rhofade)
Loperamide hydrochloride capsules USP (2 mg over-the-counter) to control symptoms of diarrhea, including traveler's diarrhea. (Brand name: None provided)
Ceftaroline fosamil for injection (400 mg and 600 mg in single-dose vials) to treat acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia in patients ages 2 months and older. (Brand name: Teflaro)
Lenalidomide capsules (2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg) for the treatment of patients with multiple myeloma. (Brand name: Revlimid)
Eliglustat capsules (84 mg) for the long-term treatment of adult patients with Gaucher disease type 1 who are extensive, intermediate, or poor CYP2D6 enzyme metabolizers, as detected by an FDA-cleared test. (Brand name: Cerdelga)
Everolimus tablets (0.25 mg, 0.5 mg, 0.75 mg, and 1 mg) for the prophylaxis of organ rejection in adult patients. (Brand name: Zortress)
Mivacurium chloride injection (10 mg/5 mL [2 mg/mL] and 20 mg/10 mL [2 mg/mL] in single-dose vials) as an adjunct to general anesthesia to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation in inpatients and outpatients. (Brand name: Mivacron)
Sunitinib malate capsules (12.5 mg, 25 mg, 37.5 mg, and 50 mg) to treat adult patients with GI stromal tumor after disease progression on or intolerance to imatinib mesylate; to treat adult patients with advanced renal cell carcinoma; as an adjuvant treatment for adult patients at high risk of recurrent renal cell carcinoma following nephrectomy; and to treat well-differentiated pancreatic neuroendocrine tumors in adult patients with unresectable locally advanced or metastatic disease. (Brand name: Sutent)
Carglumic acid tablets for oral suspension (200 mg) as an adjunctive therapy to standard of care to treat patients with acute hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency and as a maintenance therapy to treat those with chronic hyperammonemia due to NAGS deficiency. (Brand name: Carbaglu)
Romidepsin for injection (10 mg/vial in single-dose vials) to treat cutaneous T-cell lymphoma in adult patients who have received at least one prior systemic therapy. (Brand name: Istodax)
Note: The FDA states that drugs are not always commercially available immediately after approval.