Recalls, warnings, alerts
A class I recall of SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) by Baxter due to the risk of not alarming for repeated upstream occlusion events. Over five years, there have been 51 serious injuries and three deaths reported that may be related to this issue. The recall includes 277,450 devices distributed since Feb. 5, 2015.
A class I recall of certain V60 and V60 Plus Ventilators by Philips Respironics due to expired adhesive that may cause the ventilator to stop working, with or without an alarm. If the adhesive fails, it could cause the ventilator to stop providing oxygen to the patient. No related adverse events have been reported. The recall includes 1,511 devices distributed from July 29 to Aug. 11, 2021.
A class I recall of the TurboHawk Plus Directional Atherectomy System by Medtronic due to risk of tip damage during use. No related adverse events have been reported. The recall includes 686 devices distributed from Sept. 27, 2021, to Jan. 25, 2022.
A recall of certain lots of quinapril hydrochloride/hydrochlorothiazide tablets by Pfizer due to the presence of a nitrosamine impurity. The recall includes six lots of quinapril hydrochloride/hydrochlorothiazide (Accuretic) tablets, one lot of quinapril and hydrochlorothiazide tablets, and four lots of quinapril HCl/hydrochlorothiazide tablets. No related adverse events have been reported. Recalled products were distributed nationwide to wholesalers and distributors in the U.S. and Puerto Rico from November 2019 to March 2022.
A recall of 13 lots of orphenadrine citrate (100 mg) extended-release tablets by Sandoz due to the presence of a nitrosamine impurity. No related adverse events have been reported. Recalled products were distributed from August 2019 to April 2021.
A recall of seven lots of sodium acetate injection USP (400 mEq/100 mL [4 mEq/mL] in 100-mL vials by Fresenius Kabi due to the presence of particulate matter. No related adverse events have been reported. Recalled products were produced and sold in 2020 and 2021.
A recall of 11 lots of compounded injectable products by Olympia Pharmacy due to being out of specification. Recalled products include sermorelin, sincalide, hydroxocobalamin, and other injectables. No related adverse events have been reported. Recalled products were distributed to patients and health clinics.
A recall of five lots of 0.9% sodium chloride for injection USP (250 mL in Excel IV containers) by B. Braun Medical Inc. due to fluid leakage or low fill volume of the containers, potentially causing a lack of sterility. No related adverse events have been reported. Recalled products were distributed nationwide to domestic distributors from June 2 through Oct. 29, 2021.
A recall of four lots of epinephrine (SYMJEPI) injection (0.15 mg [0.15 mg/0.3 mL] and 0.3 mg [0.3 mg/0.3 mL] in prefilled single-dose syringes) by Adamis Pharmaceuticals due to a potential manufacturing defect. The defect may cause the needle to clog, preventing the dispensing of epinephrine. Recalled products were distributed nationwide and directly to customers and/or medical facilities.
A recall of certain lots of products by Plastikon Healthcare LLC due to microbial contamination. The recall includes three lots of milk of magnesia oral suspension (2,400 mg/30 mL), one lot of acetaminophen (650 mg/20.3 mL), and six lots of magnesium hydroxide (1,200 mg)/aluminum hydroxide (1,200 mg)/simethicone (120 mg/30 mL). No related adverse events have been reported. Recalled products were distributed to Major Pharmaceuticals, who shipped nationwide to hospitals, nursing homes, and clinics from May 1, 2020, to June 28, 2021.
A recall of all lots of hand sanitizer (75% isopropyl alcohol antiseptic) by Tennessee Technical Coatings Corp. due to the presence of methanol. No related adverse events have been reported. Recalled products were distributed in Tennessee to retail customers and to wholesalers, who further distributed between April and August 2020.
A warning against the use of the Renuvion/J-Plasma device by Apyx Medical for procedures intended to improve the appearance of skin through dermal resurfacing or skin contraction. While the FDA has not approved or cleared the use of this device in any procedure intended to improve the appearance of skin, the agency has received reports of serious and potentially life-threatening adverse events with use of the device for certain aesthetic procedures.
An alert about a cybersecurity vulnerability identified for the Axeda agent and Axeda Desktop Server, which are owned and supported by the computer software company PTC and are used in multiple medical devices across several manufacturers. Exploitation of the vulnerability could allow an unauthorized attacker to take full control of the host operating system and could result in changes to the operation of the medical device and impact the availability of remote support functionality. All versions of the software components are affected.
A recall of 17 lots of Jergens Ultra Healing Moisturizer (3-oz and 10-oz sizes) by Kao USA Inc. due to the presence of Pluralibacter gergoviae. The bacterium typically poses little medical risk to healthy people, but people with weakened immune systems or other health problems may be more susceptible to infections.
Authorization of a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for certain individuals. The second booster of either vaccine may be administered to those ages 50 years and older at least four months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine. The second booster of the Pfizer-BioNTech vaccine may be administered to certain immunocompromised individuals ages 12 years and older, and that of the Moderna vaccine may be administered to certain immunocompromised individuals ages 18 years and older, at least four months after the first booster dose of any authorized or approved COVID-19 vaccine. Eligible immunocompromised patients are those who have had solid organ transplantation or who are living with conditions considered to have an equivalent level of immunocompromise. The FDA based its authorization decision on emerging evidence suggesting that a second booster dose of an mRNA COVID-19 vaccine improves protection against severe COVID-19 and is not associated with new safety concerns. The authorization applies to the FDA-authorized Pfizer-BioNTech and Moderna COVID-19 vaccines as well as the FDA-approved Comirnaty and Spikevax vaccines.
A class I recall of STANDARD Q COVID-19 Ag Home Tests by SD Biosensor because they were distributed to U.S. customers without authorization, clearance, or approval from the FDA. There have been no related reports of injuries, deaths, or adverse events. The recall includes up to 397,700 units distributed from Aug. 26, 2021, to Jan. 30, 2022.
A class I recall of COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests by LuSys Laboratories Inc. because they are not authorized and cannot be legally marketed and distributed in the U.S. There have been no related reports of injuries, deaths, or adverse events. The recall includes 164,250 units distributed from June 1, 2020, to July 21, 2021.
A class I recall of certain lots of point-of-care DiaTrust COVID-19 Ag Rapid Tests by Celltrion USA due to a high number of false-positive reports. There have been no related reports of injuries, deaths, or adverse events. The recall includes 45,500 units distributed from June 2 to Dec. 21, 2021.
A recall of the Flowflex COVID-19 Antigen Home Test by ACON Laboratories Inc. because of the distribution of unauthorized, adulterated, and misbranded counterfeit products having the trade name Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing). The manufacturer is not importing these products into the U.S., as they are only authorized for sale in Europe and other markets. There have been no related reports of adverse events.
An announcement that the COVID-19 treatment sotrovimab is no longer authorized for use in certain U.S. regions due to the high frequency of the omicron BA.2 subvariant and data showing that the authorized dose of the drug is unlikely to be effective against that subvariant. Until further notice, sotrovimab may not be administered for treatment under the emergency use authorization in the following regions: Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont (HHS Region 1), New Jersey, New York, Puerto Rico, and the Virgin Islands (HHS Region 2).
Authorization of an extension for the shelf life of the refrigerated Janssen COVID-19 Vaccine, from six to nine months, allowing the product to be stored at 2 °C to 8 °C. The FDA authorized the extension after a thorough review of data submitted by the manufacturer. The extension now applies to all refrigerated vials of the vaccine that have been held in accordance with the manufacturer's storage conditions.
A safety communication alerting people of the potential for harm if FDA-authorized at-home COVID-19 tests are not used according to the manufacturer's test instructions. The FDA has received reports of injuries caused by the incorrect use of at-home COVID-19 tests, such as people putting the test chemicals in their eyes, because the small vials of test solution were mistaken for eye drops. The agency also reminded people to keep the tests out of reach of children and pets, as it is also aware of children putting small plastic vials in their mouths and swallowing test solution.
A letter to clinicians providing recommendations, including conservation strategies, for prefilled saline flush syringes, which are in shortage. The U.S. is experiencing interruptions in the supply of prefilled 0.9% sodium chloride IV lock/flush syringes due to an increase in demand during the COVID-19 public health emergency, as well as recent vendor supply chain challenges, including the permanent discontinuance of certain syringes, the FDA said. The agency advised health care personnel to use preservative-free, sterile 0.9% sodium chloride single-dose vials if prefilled sterile 0.9% sodium chloride syringes are unavailable, among other recommendations.
Authorization of sale for several tobacco-flavored electronic nicotine delivery system products from Logic Technology Development LLC under the Logic Vapeleaf, Logic Power, and Logic Pro brands, including devices. The products were authorized after the agency's review of the product applications concluded that the likely benefit for adult smokers who significantly reduce their cigarette use (or who switch from cigarettes completely) outweighs the risk to youth, provided that the company follows postmarketing requirements to reduce youth access and exposure to their marketing.
Ganaxolone (Ztalmy) to treat seizures associated with cyclin-dependent kinase-like 5 deficiency disorder (CDD) in patients ages 2 years and older. This is the first treatment for seizures associated with CDD and the first treatment specifically for CDD. The most common side effects include sleepiness, fever, excessive saliva or drooling, and seasonal allergy. Taking the drug with central nervous system depressants, including alcohol, may increase sleepiness. The drug may cause other serious side effects, including suicidal thoughts or actions.
First-time generic approvals
Budesonide and formoterol fumarate dihydrate inhalation aerosol for the treatment of asthma in patients ages 6 years and older and for the maintenance treatment of airflow obstruction and to reduce exacerbations in patients with chronic obstructive pulmonary disease. (Brand name: Symbicort)
Dapagliflozin tablets (5 mg and 10 mg) as an adjunct to diet and exercise to improve glycemic control. (Brand name: Farxiga)
Digoxin tablets USP (0.0625 mg, 0.125 mg, and 0.25 mg) for the treatment of mild to moderate heart failure in adults. (Brand name: Lanoxin)
Lacosamide tablets USP (50 mg, 100 mg, 150 mg, and 200 mg) for the treatment of partial-onset seizures in patients ages 4 years and older. (Brand name: Vimpat)
Nalmefene hydrochloride injection (2 mg/2 mL [1 mg/mL] in single-dose vials) for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids, as well as for the management of known or suspected opioid overdose. (Brand name: Revex)
Tolvaptan tablets (15 mg and 30 mg) for the treatment of clinically significant hypervolemic and euvolemic hyponatremia, including in patients with heart failure and syndrome of inappropriate antidiuretic hormone. (Brand name: Samsca)
Maraviroc tablets (150 mg and 300 mg) for the treatment of only CCR5- tropic HIV-1 infection in adults and pediatric patients weighing at least 2 kg. (Brand name: Selzentry)
Apomorphine hydrochloride injection (30 mg/3 mL [10 mg/mL] in single-patient-use glass cartridges for use with a reusable pen injector) for the acute, intermittent treatment of hypomobility, “off” episodes (“end-of-dose wearing off” and unpredictable “on/off” episodes) associated with advanced Parkinson's disease. (Brand name: Apokyn)
Note: The FDA states that drugs are not always commercially available immediately after approval.