Sagent Pharmaceuticals, Inc.

The recall was attributed to a customer complaint of potential particulate matter from the drug's stopper. Amid a shortage of standard-of-care chemotherapy drugs, Sagent Pharmaceuticals is pulling two lots of its docetaxel injection from U.S. shelves after receiving a report of potential particulate matter in a vial. The recalled batches were distributed nationwide between October 2023 and April 2024 and are set to expire this December. Customers are being alerted by way of a FedEx package that includes instructions and necessary arrangements for the return of the product, according to an FDA notice. Intravenous injection of a product that contains particulate matter poses serious health risks. So far, Sagent has not received word of any adverse events related to the recalled product. Docetaxel is a generic chemotherapy used to treat a number of cancer types. Various doses of the drug already face shortages in the U.S., according to the American Society of Health-System Pharmacists (ASHP). The FDA does not list a docetaxel shortage in its own database. Some docetaxel offerings from Mylan, Pfizer, Baxter, Sagent, Sandoz and Winthrop, among others, are still available, ASHP notes. Back in September, Becker’s Hospital Review reported a shortage encompassing three-fourths of the U.S. docetaxel supply. Doctors are recommended to weigh the available supply of the treatment before starting patients on a docetaxel-containing regimen, ASHP notes, as “no single agent” can be substituted for the chemo. Generic chemotherapy shortages have run rampant for more than a year, prompting difficult choices for oncologists and increased danger for patients as supply is rationed. Alternative treatments can sometimes be “unconventional and unproven,” not to mention risky and extremely costly, the American Society of Clinical Oncologists (ASCO)’s chief medical officer Julie Gralow said in prepared testimony for a House hearing earlier this year. The total number of U.S. drug shortages was at a record high in the first quarter, ASHP reported. The group was tracking 323 shortages at that time.

SCHAUMBURG, Ill., May 28, 2024 /PRNewswire/ -- Sagent Pharmaceuticals today announced the voluntary nationwide recall of two lots of Docetaxel Injection, USP (80 mg per 8 mL multi-dose vials and 160 mg per 16 mL multi-dose vials). The product was distributed by Sagent Pharmaceuticals. Sagent has initiated this voluntary recall of Docetaxel Injection, USP to the User Level as the result of a customer complaint due to potential presence of particulate matter from the stopper in the drug product. Risk Statement: Intravenous administration of an injectable product that contains particulate matter may result in serious adverse events. Potential complications related to injection of particles include inflammation of a vein, granuloma, and blockage of blood vessels in the heart, lungs or brain which can cause stroke or life-threatening blood clot events. The frequency and severity of these adverse events could vary depending upon a variety of factors including the size and number of particles in the drug product, patient comorbidities (such as age, compromised organ function), and presence or absence of vascular anomalies. To date, Sagent Pharmaceuticals has not received any reports of adverse events related to this recall. The Docetaxel Injection, USP, label and affected lot numbers with Expiration Dates and NDC number can be found in the table below. Product was distributed Nationwide from October 11, 2023, to April 11, 2024. Customers are being notified by a FedEx package that includes arrangements for return of all recalled product. Customers are instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return the recalled lots listed above. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. Consumers/distributors/retailers that have product which is being recalled should stop using product and return the recalled product. The necessary form by which to document this information as well as other information regarding this recall is available at . Customers with any questions about returning unused product are directed to the customer call center at (866) 625-1618 M-F, 8am-5pm CST, option 1. Healthcare workers who have medical questions about Docetaxel Injection, USP, may contact Medical Affairs (866) 625-1618, Option 3, M-F, 8am-5pm CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product. 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: medwatch • Regular Mail or Fax: Download form or call 1-800-FDA-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. View original content to download multimedia: SOURCE Sagent Pharmaceuticals

Portfolio focused on high-quality FDA approved products to treat patients in acute care hospitals, outpatient clinics and physician offices; pursuing 25+ new products over next two years Differentiated business model ensures supply chain resiliency through established manufacturing partner network Seasoned team with proven track record of launching critical medications includes Jeffrey Yordon, CEO Company to highlight expertise at CPhI Conference in Barcelona on October 24-26 SCHAUMBURG, Ill.--(BUSINESS WIRE)-- Avenacy, a specialty pharmaceutical company focused on developing, manufacturing, and delivering critical medications, today announced its launch. Supported by a vast global network of development and manufacturing partners, Avenacy is prepared to meet the needs of today’s dynamic drug supply chain while ensuring quality of care to patients. Through a rigorous and optimized selection process, Avenacy is building out a portfolio of high-quality FDA approved products capable of delivering sustainable growth while providing reliability, safety, and convenience for customers. Products will cover a range of critical medications used to treat patients in various medically-supervised settings, from acute care hospitals to outpatient clinics and physician offices. All products will feature Avenacy’s unique packaging and labeling designed to assist healthcare providers with accurate medication selection, thereby supporting a reduction in administration errors and improper dosing. Avenacy will also provide ready-to-use formulations of essential medications to help address dosing inaccuracies, enhance patient safety, and streamline efficiency – all with the ultimate goal of improving patient care. “At Avenacy, we are advancing a partnership-driven business model that will enable us to be cost-efficient and nimble to market by focusing on product investment while minimizing manufacturing costs. With nearly 20 development and manufacturing partners already in place across five key geographies, we are well-equipped to begin fulfilling the needs of healthcare systems and providers,” said Jeff Yordon, Co-Founder and CEO of Avenacy. “Our team brings a long-standing legacy in specialty pharmaceuticals and a reputation for prioritizing quality, safety, and reliability. Everything we do, from product selection to partner assessment and supply chain management, will be underpinned by an unwavering commitment to applying the highest industry standards, championing patient safety, and ensuring a dependable drug supply.” The Avenacy team and its founders Jeffrey Yordon and Kam Phulwani have a proven track record in building successful specialty pharmaceutical companies. The Company is led by Jeffrey Yordon, who previously served as COO of Athenex, Inc. and President of Athenex Pharmaceutical Division, a successful specialty injectable business that launched over 50 products and delivered nearly 40% CAGR revenue growth from 2017-2022. Before joining Athenex, Mr. Yordon founded and led Sagent Pharmaceuticals, a global specialty pharmaceutical company, which was ultimately acquired by Nichi-Iko Pharmaceuticals Company in 2016. Drawing on prior experience and success in specialty pharmaceuticals, Kam Phulwani made a significant investment to fund Avenacy and its expanding pipeline of products for the U.S. market. The management team brings over 245 collective years of industry experience spanning pharmaceutical development, quality, manufacturing, and sales. Avenacy is well-positioned to address key gaps in the U.S. drug supply landscape. The Company employs a multifaceted strategy incorporating rigorous quality standards, a global partnership model, and deep relationships across the drug development and manufacturing ecosystem, to ensure a dependable and resilient drug supply. Additionally, the industry has been increasingly plagued by shortage issues, with the number of active drug shortages peaking at 301 in the first quarter of 2023. As an essential medicines provider, Avenacy is committed to acquiring products historically facing lower supply, and has an open dialogue in place with the U.S. Food and Drug Administration (FDA) about products at risk for shortages. Avenacy will be showcasing its differentiated business model, diverse partner network, and experienced leadership team at this year’s CPhI 2023 Conference, taking place in Barcelona from October 24-26. During this time, the Company will be hosting meetings with potential partners, customers, and investors, as it continues to expand its global presence. About Avenacy Avenacy is a U.S.-based specialty pharmaceutical company focused on developing, manufacturing, and delivering critical medications used to treat patients in various medically supervised settings, from acute care hospitals to outpatient clinics and physician offices. Through a rigorous and optimized selection process, the Company is building out a pipeline of high-quality FDA approved products in order to ensure a resilient portfolio that can meet the needs of today’s dynamic drug supply chain. With an experienced team, commitment to quality and reliability, and product offerings intended to facilitate safe and efficient patient care, Avenacy strives to be a trusted partner for essential medications. Avenacy was launched in 2023 and is headquartered in Schaumburg, IL. For more information, please visit . View source version on businesswire.com: Contacts FTI Consulting Avenacy@fticonsulting.com Source: Avenacy View this news release online at: