WICHITA, Kan., Oct. 20, 2020 /PRNewswire/ -- Fagron Sterile Services US (FSS), a leading 503B pharmaceutical outsourcing provider, today announced a new product innovation – the launch of the first sterile topical anesthetic LET Gel produced at scale through cGMP compliant operations.
LET Gel is a topical anesthetic consisting of Lidocaine, EPINEPHrine, and Tetracaine which is commonly used in conjunction with suturing patients in hospital emergency rooms, urgent care centers, pediatrician offices or by other qualified health care providers.
In a 2019 Food and Drug Administration (FDA) warning, the agency shared significant concerns and dangers of using non-sterile anesthetic for wound care. A recent FDA recall notification states:
"Non-sterile product has the potential to result in an increased chance of infection at the site of administration during open wound care. The use of this or other non-sterile products in wound treatment may increase the risk of infection, especially for immunocompromised patients, the elderly, or children."
FSS leveraged pharmaceutical expertise spanning three decades to quickly develop the first Sterile Topical LET Gel in the industry – listening to both customer needs and the FDA. At this time, LET Gel from Fagron Sterile Services US, is the only Sterile Topical LET Gel on the market from a 503B Outsourcing Facility or compounding pharmacy.
Subject matter experts from FSS' Laboratory Services, Validation, Operations and Quality collaborated to ensure the consistency of a sterile gel by employing a sophisticated, multi-step process validation and following cGMP compliant operations at FSS' state-of-the-art facilities. The manufacturing process has been fully validated with Aseptic Process Simulation (Media Fill) and Stability Studies proving product efficacy throughout the life of its expiry date.
Sterile Topical LET Gel from FSS dispenses in a convenient 3 mL unit dose syringe, individually labeled and complete with enhanced safety warnings to minimize risk of misadministration. As a 503B Outsourcing Facility, FSS can distribute LET Gel for shelf stock; no need for patient specific prescriptions.
FSS' Sterile Topical LET Gel demonstrates FSS' commitment to innovative solutions and partnership with their customers to provide reliable, high-quality medications for their patient-care needs.
Visit fagronsterile.com/let-gel to learn more and set up a free consultation or contact your dedicated Sales Representative today.
About Fagron Sterile Services US
Fagron Sterile Services US (FSS), a top-tier DEA and FDA-registered 503B Outsourcing Provider, produces reliable supply of high-quality sterile medications with cGMP compliant operations for patient-focused healthcare facilities across North America. FSS' team employs expertise in legal and regulatory compliance, pharmaceutical manufacturing and repackaging, leveraging industry leading automation, advanced environmental monitoring and sophisticated in-house quality testing labs. Batches are validated to support Beyond Use Dating (BUD) and only released after successful sterility, particulate matter and potency testing are complete. FSS offers a broad product portfolio across Operating Room Anesthesia, Ophthalmics, Pain Management and other Specialty Presentations, and holds Integrated Delivery Network (IDN) agreements within all major GPOs.
SOURCE Fagron Sterile Services