Recalls and warnings
A class I recall of the Cortrak*2 Enteral Access System by Avanos Medical due to the risk of misplaced enteral tubes causing patient harm. There have been 60 injuries and 23 patient deaths related to misplacement of nasogastric feeding tubes while using the system since 2015. Adverse events reported include respiratory failure, pneumothorax, perforation, pneumonia, and pleural effusion. The recall includes 629 devices distributed from April 1, 2016, to Jan. 1, 2022.
A recall of five lots of quinapril hydrochloride (Accupril) tablets by Pfizer due to excess levels of a nitrosamine impurity, N-nitroso-quinapril. No related adverse events have been reported. Recalled products were distributed nationwide to wholesalers and distributors in the U.S. and Puerto Rico from December 2019 to April 2022.
A recall of one batch of insulin glargine (insulin glargine-yfgn) injection (100 units/mL [U-100]) by Mylan Pharmaceuticals Inc. due to the potential for the label to be missing on some vials. The recall does not pertain to the branded interchangeable biosimilar, Semglee. No related adverse events have been reported. The batch was distributed in the U.S. between Dec. 9, 2021, and March 4, 2022.
A recall of one lot of idarubicin hydrochloride injection USP (5 mg/5 mL vials) by Teva Pharmaceuticals due to the presence of particulate matter identified as silica and iron oxide. No related adverse events have been reported. The recall includes 1,565 vials distributed nationwide to four wholesale customers from Dec. 4, 2020, through Aug. 18, 2021.
A warning about the risk of false results with genetic noninvasive prenatal screening tests. Such false results include reporting a genetic abnormality when the fetus does not actually have one. The FDA is aware of reports that patients and clinicians have made critical health care decisions based on results from these screening tests alone, without confirmatory testing. While clinicians widely use these tests, none have yet been authorized, cleared, or approved by the FDA.
A warning not to use products intended to be sterile produced by FarmaKeio Superior Custom Compounding due to a lack of sterility assurance. An FDA inspection observed conditions that could cause contamination or otherwise pose risks to patients, the agency said.
A warning not to purchase or use certain Artri and Ortiga products due to potentially dangerous active ingredients not listed on the product label. FDA testing found the undeclared drug ingredients dexamethasone, diclofenac sodium, and methocarbamol. Products containing hidden drug ingredients include Artri Ajo King, Artri King, Ortiga Mas Ajo Rey, and Ortiga Mas Ajo Rey Extra Forte. The FDA has received related reports of adverse events, including liver toxicity and death, and is investigating the distribution of these products in the U.S.
A recall of all lots of Suave 24-Hour Protection Aerosol Antiperspirant Powder and Suave 24-Hour Protection Aerosol Antiperspirant Fresh by Unilever due to the presence of slightly elevated levels of benzene, a human carcinogen. The affected products were in limited distribution at U.S. retail stores and online.
A recall of two lots of Mickey Mouse and Mandalorian Hand Sanitizer by Best Brand Consumers Products due to the presence of methanol and benzene, respectively. The imported lots were produced by a third-party manufacturer.
Restrictions of the authorized use of the Johnson & Johnson (Janssen) COVID-19 Vaccine to certain individuals. The vaccine is now only authorized for use in individuals ages 18 years and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate and in those ages 18 years and older who elect to receive it because they would otherwise not receive a COVID-19 vaccine. After conducting an updated analysis, evaluation, and investigation of reported cases, the FDA has determined that the risk of thrombosis with thrombocytopenia syndrome warrants limiting the authorized use of the vaccine. However, the agency determined that the known and potential benefits of the vaccine for the prevention of COVID-19 outweigh the known and potential risks for individuals in whom the vaccine is now authorized.
An announcement that sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to increases in the proportion of COVID-19 cases caused by the omicron BA.2 subvariant. Data showed the authorized dose of the drug is unlikely to be effective against the subvariant, which the CDC estimated to represent more than 50% of COVID-19 cases in all HHS U.S. regions.
An emergency use authorization for the InspectIR COVID-19 Breathalyzer test. The test is the first COVID-19 diagnostic test that detects chemical compounds associated with SARS-CoV-2 infection in breath samples. It is indicated for adults without symptoms or other epidemiological reasons to suspect COVID-19 and is authorized to be performed in environments where the patient specimen is both collected and analyzed, such as doctors' offices, hospitals, and mobile testing sites, using an instrument about the size of a piece of carry-on luggage. The test can provide results in under three minutes, and positive results should be confirmed with a molecular test.
An alert not to use counterfeit at-home over-the-counter COVID-19 diagnostic tests. Such tests, which are made to look like authorized tests, are being distributed or used in the U.S. but are not authorized, cleared, or approved by the FDA. Some signs that a test may be counterfeit include poor print quality of images or text on the label, grammatical or spelling errors, and missing information on the outside box label for the product (e.g., lot number, expiration date, barcode).
Authorization of an extension for the shelf life of the Tris/Sucrose and PBS/Sucrose formulations of the Pfizer-BioNTech COVID-19 Vaccine. The authorization allows the frozen vials to be stored in an ultra-low-temperature freezer at -90 °C to -60 °C for up to 12 months from the date of manufacture.
Authorization of an extension for the shelf life of the refrigerated Janssen COVID-19 Vaccine, allowing for storage at 2 °C to 8 °C for 11 months. The vaccine was previously authorized to be stored for up to nine months.
An announcement that the FDA is seeking public comment on a potential change to the existing Opioid Analgesic Risk Evaluation and Mitigation Strategy that would require opioid analgesics used in outpatient settings to be dispensed with prepaid mail-back envelopes. The change would provide an additional convenient disposal option for patients beyond those already available, including flushing and takeback events. It would also include patient education by pharmacists on safe disposal of opioids. The FDA is seeking public comments from patients, clinicians, and others until June 21, 2022, although it welcomes comments at any time.
Proposed rules that would prohibit menthol as a characterizing flavor in cigarettes and prohibit all nontobacco flavors in cigars. When finalized, the proposed menthol product standard would reduce the appeal of cigarettes, particularly to youth and young adults, and improve the health of current menthol smokers by decreasing consumption, the FDA said.
A letter to clinicians to increase awareness about the potential risk of airway obstruction when using silicone-based electromyogram endotracheal tubes (Medtronic NIM Standard Reinforced EMG Endotracheal Tube and Medtronic NIM Contact Reinforced EMG Endotracheal Tube). The FDA has received reports of serious adverse events and deaths for these devices after airway obstruction and ventilation failure. The root cause and incidence rate of these events are unknown.
A letter to clinicians alerting them to the possibility that patients who have the Medtronic HeartWare Ventricular Assist Device System and appear to present with pump thrombosis may have a welding defect in the internal pump, causing it to malfunction. The company is investigating which pumps may be affected. The FDA does not recommend the elective removal of properly functioning systems; decisions about removal or exchange of the system should be made by clinicians and patients together on a case-by-case basis, considering patients' clinical status and surgical risks, the FDA said.
A safety communication encouraging hospitals and endoscopy facilities to completely transition to innovative duodenoscope designs that include disposable components, such as disposable endcaps, or to fully disposable duodenoscopes, the FDA said, noting that the use of a removable component to facilitate cleaning leads to significantly less contamination. Interim results from one duodenoscope model with a removable component showed a contamination rate of 0.5%, compared with as high as 6% among older duodenoscope models.
A letter to clinicians alerting them of a change in reprocessing methods for certain urological endoscopes by Karl Storz. The company initiated a recall and issued an urgent field safety notice instructing users to discontinue all high-level disinfection methods for all affected urological endoscopes and discontinue liquid chemical sterilization for most of them. The affected devices should be sterilized after each use by an appropriate sterilization method recommended in the instructions for use.
A letter to clinicians reminding them about the intended use of radiological computer-aided triage and notification devices for intracranial large-vessel occlusion. Such devices only flag radiological exams with suspected findings and should never be used as a replacement for informed interpretation by an imaging physician, the FDA said.
Tirzepatide injection (Mounjaro) as an addition to diet and exercise to improve blood sugar control in adults with type 2 diabetes. The drug is a first-in-class medicine that activates both the glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide receptors, leading to improved blood sugar control. It is administered subcutaneously once weekly, with the dose adjusted as tolerated to meet blood sugar goals. Three different doses (5 mg, 10 mg, and 15 mg) were evaluated in five clinical trials as either a standalone therapy or as an add-on to other diabetes medicines. The trials compared the drug's efficacy to placebo, a GLP-1 receptor agonist (semaglutide), and two long-acting insulin analogs in participants with an average body mass index of 32 to 34 kg/m2. On average, participants randomized to receive the 15-mg dose lowered their HbA1c level by 1.6% more than placebo when used as stand-alone therapy and by 1.5% more than placebo when used in combination with a long-acting insulin. In comparative trials, participants who received the 15-mg dose lowered their HbA1c level by 0.5% more than semaglutide, by 0.9% more than insulin degludec, and by 1.0% more than insulin glargine. Weight loss associated with the drug was also higher compared with placebo or the other diabetes treatments. Side effects include nausea, vomiting, diarrhea, decreased appetite, constipation, upper abdominal discomfort, and abdominal pain. The drug is not indicated for use in patients with type 1 diabetes and has not been studied in patients with a history of pancreatitis. In addition, it causes thyroid C-cell tumors in rats; it is unknown whether it causes such tumors, including medullary thyroid cancer, in humans.
The CartiHeal Ltd. Agili-C device to treat defects or lesions that can occur in cartilage covering bones in the knee joint. The device is a small cylinder of material implanted below the defect or lesion in the cartilage onto the underlying bone, where it gradually resorbs and is replaced by new cartilage. It is made of porous, biocompatible, and biodegradable material made from natural calcium carbonate derived from purified, inorganic coral's external skeleton.
An expanded indication for the TransMedics Organ Care System Heart System. This is the first device indicated for the preservation of donation-after-circulatory-death hearts in a warm, beating state. The system was previously indicated for the preservation of donation-after-brain-death hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of prolonged static cold storage.
Marketing of Fitbit's Irregular Rhythm Notifications software to be used with certain wrist-worn consumer products to analyze pulse rate data and identify episodes of irregular heart rhythms that may suggest possible atrial fibrillation. The software is designed to notify the user when an irregular heart rhythm occurs while the user is not moving and is intended for over-the-counter use. It is not intended to diagnose or treat atrial fibrillation, for use in people under age 22 years, or for use in those previously diagnosed with atrial fibrillation.
First-time generic approvals
Doxylamine succinate and pyridoxine hydrochloride extended-release tablets (20 mg/20 mg) for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. (Brand name: Bonjesta)
Sodium phosphates injection USP (15 mM P/5 mL [3 mM P/mL], 45 mM P/15 mL [3 mM P/mL], and 150 mM P/50 mL [3 mM P/mL] in single-dose vials) as a source of phosphorus, for addition to large-volume IV fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. (Brand name: None provided)
Methylphenidate transdermal system (1.1 mg/h, 1.6 mg/h, 2.2 mg/h, and 3.3 mg/h) for the treatment of attention deficit hyperactivity disorder. (Brand name: Daytrana Transdermal System)
Lactated Ringer's and 5% dextrose injection USP in single-dose containers for the parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient. (Brand name: None provided)
Note: The FDA states that drugs are not always commercially available immediately after approval.