Ethyl Aminobenzoate

TARRYTOWN, N.Y., Dec. 22, 2023 (GLOBE NEWSWIRE) -- Insight Pharmaceuticals, a Prestige Consumer Healthcare Inc. company (“Insight”), is voluntarily recalling one lot of Americaine® 20% Benzocaine Topical Anesthetic Spray to the consumer level. While benzene is not an ingredient in any Americaine® 20% Benzocaine Topical Anesthetic Spray products, a recent review by our manufacturer and their third-party lab found that a sample from one lot of the product showed a low level of benzene came from the propellant that sprays the product out of the can. Importantly, no other lots of Americaine® 20% Benzocaine Topical Anesthetic Spray (either before or after this batch code) are in the scope of this recall and may continue to be used by consumers safely and as intended. Risk Statement: Benzene is classified as a human carcinogen. Exposure to benzene can occur by inhalation, orally, and through the skin and it potentially can result in cancers including leukemia and blood cancer of the bone marrow and blood disorders which can be life threatening. Insight is recalling these products out of an abundance of caution. To date, the Company has not received any serious adverse events related to this recall. Benzene is ubiquitous in the environment. Humans around the world have daily exposures to it indoors and outdoors from multiple sources. Americaine® 20% Benzocaine Topical Anesthetic Spray is packaged in white aerosol cans with Teal caps with Lot codes located on the bottom of the can. Samples of the recalled lot below have been found to contain trace levels of Benzene related to the propellant that sprays the product out of the can. Benzene is not an ingredient in any Americaine products. Product NDC Lot Code Expiration Package Size Americaine® 20% Benzocaine Topical Anesthetic Spray 63736-378-02 1A16420 01/25 2 oz / 57 g The affected Americaine® 20% Benzocaine Topical Anesthetic Spray lot was distributed nationwide in the United States through a limited number of retailers and online. Insight has notified retailers via overnight mail to remove any remaining recalled product from shelves and follow the instructions provided in the Drug Recall Notification. The company will also offer reimbursement for consumers who have purchased Americaine® 20% Benzocaine Topical Anesthetic Spray marked with the lot code in the table above. Consumers can contact Insight Pharmaceuticals via e-mail at medicalaffairs@prestigebrands.com, through its website at , or by phone at (800) 344-7239 on Monday – Friday 8:30-5:30 eastern time to receive a full refund by providing a picture of the bottom of the can of the Americaine® 20% Benzocaine Topical Anesthetic Spray with the affected lot number. Consumers that have product which is being recalled should stop using the product immediately and appropriately discard after taking the picture. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this anesthetic product. No serious adverse events have been reported to date. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online: Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. A photo accompanying this announcement is available at . Investor Relations Contact Phil Terpolilli, CFA, 914-524-6819 irinquiries@prestigebrands.com Americaine® 20% Benzocaine Topical Anesthetic Spray Americaine® 20% Benzocaine Topical Anesthetic Spray

DUBLIN, Nov. 7, 2023 /PRNewswire/ -- The "The US Anesthesia Drugs and Devices Market (by segment, Type, Drug Product, & Device Product): Insights and Forecast with Potential Impact of COVID-19 (2022-2027)" report has been added to ResearchAndMarkets.com's offering. The US anesthesia drugs and devices market is poised for significant growth, with a projected value of US$6.83 billion in 2023, experiencing a robust CAGR of 6.78% during the forecasted period. Anesthesia, the use of drugs to alleviate pain during medical procedures, is essential in the healthcare industry and is administered through various means such as injection, inhalation, topical application, and more. Market Segmentation The US anesthesia drugs and devices market is divided into two primary segments: anesthesia drugs and anesthesia devices. Among these segments, anesthesia drugs currently hold the majority share, while the anesthesia devices segment is expected to experience substantial growth due to increased healthcare expenditure in the region. Types and Products In terms of types, the US anesthesia drugs market is categorized into General, Local, and other anesthesia. The General anesthesia drug segment dominates the market, followed by local anesthesia drugs. The development of novel anesthesia drugs through pharmaceutical R&D is expected to create growth opportunities in the "other anesthesia drugs" segment. When considering device products, the market is segmented into advanced, basic, and integrated anesthesia devices. The advanced segment holds the largest share in the market, followed by integrated anesthesia devices. Ongoing advancements in anesthesia monitoring devices and the demand for improved monitoring contribute to the growth of the advanced anesthesia monitoring devices market. The market is further categorized by drug product into Bupivacaine, Ropivacaine, Lidocaine, Chloroprocaine, Prilocaine, Benzocaine, and other local anesthetics. Lidocaine anesthesia drugs have the highest market share, followed by Bupivacaine and Ropivacaine. The market is anticipated to grow due to increasing patient populations and a rise in medical and surgical procedures. Key Drivers and Challenges Driver: Increase in Monitored Anesthesia Use The adoption of Monitored Anesthesia Care (MAC) is on the rise. MAC involves specific anesthesia services for procedures performed under local anesthesia with sedation and analgesia, allowing patients to maintain consciousness. Patients are opting for monitored anesthesia to ensure satisfaction during surgeries, leading to increased usage of anesthesia equipment and drugs. Challenge: Side Effects of Anesthesia While anesthesia is generally administered by anesthesiologists, it can sometimes lead to side effects, including nausea, headache, vomiting, and shivering, among others. General anesthetics can affect the central nervous system, causing drowsiness and coordination problems. These side effects can deter some patients and impact the growth of the anesthesiology market. Trend: Growth of Ambulatory Surgical Centers (ASC) The establishment of ambulatory surgical centers (ASCs) is escalating due to an aging population and the prevalence of chronic diseases. ASCs offer improved reimbursement and a reduced risk of healthcare-associated infections, attracting more patients. This growth in ASCs is driving the demand for anesthesia drugs and devices. COVID-19 Analysis The COVID-19 pandemic led to increased utilization of intensive care unit (ICU) ventilators and anesthesia machines for longer-term ventilation. Anesthesia drugs were used during longer-term ventilation with anesthesia machines. Initially, anesthesia drug demand decreased in 2020 due to postponed or canceled surgeries. However, as elective surgeries resumed, anesthesia drug consumption increased. Key Players The US anesthesia drugs and devices market is competitive and features several major players, including Baxter International Inc., Envision Healthcare Corporation (KKR & Co. Inc.), Becton, Dickinson and Company, TeamHealth (Blackstone), Teleflex Incorporated, Dragerwerk AG & Co. KGaA, B. Braun Avitum AG (Braun), 3M Company, Abbvie Inc., AstraZeneca Plc, Abbott Laboratories, ICU Medical, Inc., SunMed LLC, and General Electric Company. Top Impacting Factors Growth Drivers Rising Geriatric Population Growing Healthcare Expenditure Increase in Monitored Anesthesia Use Increase In Number Of Approval For Anesthesia Drugs Challenges Side Effects of Anesthesia Lack of Skilled Anesthesiologist Trends Escalating Establishment of Ambulatory Surgical Centers (ASC) Technological Enhancement of Anesthesia Devices For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. 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