06-18-2019 RXQ Compounding, LLC Issues Voluntary Nationwide Recall of All Sterile Products within Expiry and Voluntarily Cessation of Production Due to the Lack of Sterility Process Assurance
Inside Sales & Customer Service Manager
RXQ Compounding, LLC
340 West State Street, Unit 9
Athens, OH 45701
Phone (866) 280-0031
Direct (740) 331-4202
Fax (740) 994-3887
FOR IMMEDIATE RELEASE – June 18, 2019 – Athens,Ohio, RXQ Compounding, LLC (“RXQ”) “) is voluntarily recalling all sterile human and animal products within expiry to the user leveldue to lack of sterility process assurance associated with the production of the Company’s sterile products. In addition, RXQ is voluntarily ceasing all sterile production at its current location as RXQ transitions into the Company’s new outsourcing facility.
Administration of a non-sterile product that is intended to be sterile by subcutaneous, intramuscular, intravenous or ocular routes of administration may result in serious injury or death.
To date, RXQ has not received reports of any adverse events related to the sterile products being recalled. However, RXQ is recalling the sterile products in an abundance of caution.
All lots of unexpired sterile drug products produced at the Athens, Ohio location are being recalled. RXQ’s products were distributed to hospitals and practitioners nationwide.
For a full listing of the products, including lot numbers and expiration dates, being recalled please follow this link: https://rxqcompounding.com/Recall-List.pdf
RXQ is notifying its customers by letter and is arranging for return of all recalled products. Hospitals and practitioners that have these products being recalled should stop using them immediately.
Consumers with questions regarding this recall can contact RXQ between 9 a.m. and 5 p.m. EST by phone at (740) 331-4202 or email: Brian.Post@RXQCompounding.com.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug 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: fda.gov/medwatch /report.htm
- Regular Mail or Fax: Download form fda.gov/MedWatch/getforms.htm 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
- For unapproved animal drug products, you also should report the problem to the manufacturer or distributor shown on the label and to the store where you purchased the product
- If you have a question about ADE reporting or need a hard copy of the form, contact CVM by email at AskCVM@fda.hhs.gov, by phone at 1-888-FDA-VETS (1-888-332-8387)
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
We are excited to announce that RXQ Compounding, LLC is now licensed to ship to Mississippi. Please call us at 866-280-0031 to create an account and start ordering today!
Spring is finally here and RXQ wants to remind you to do some Spring Cleaning! This week, invest some time into spring cleaning and organizing. We urge you to review your stock of vials and syringes by tossing out any products that have reached their beyond use date (BUD date). Try stocking your oldest bottles in front so they are used first and less likely to go out of date. Do not forget that multi-dose vials are only recommended for 28 days after their first use.
03-12-2018 – The walls are going up on our second clean room this week. #RXQ #RXQ503B #503B #AlbanyOH
03-12-2019 – RXQ Compounding, LLC is excited to announce we have Thiamine HCL 100 mg/mL (MDV) injection available. Please contact your sales representative or call us directly at 866-280-0031 for pricing information today!#RXQ #RXQ503B #503B
For a limited time, Potassium Chloride 15% (2 meq/mL) injectable solution vials with a BUD date of 3/31/2019 are being heavily discounted by 33%. Minimum amount to receive this discount is 5 vials. To redeem this deal, you must mention or write the following code with your order: KCL33. Contact your sales representative or call 866-280-0031 to place an order today!
03-05-2019 – It’s official… RXQ Compounding, LLC can now ship to the #VirginIslands!
02-28-2019 – Excited to announce our 14,000 pound generator was safely lifted into place at our Albany location. A big thank you goes out to Anthony and the Proline Electric team for all of their hard work. #RXQ #RXQ503B #progress #construction
02-28-2019 – RXQ construction project delayed, tax abatement extended – By STEVE ROBB Messenger staff journalist
A tax abatement previously approved for expansion of RXQ Compounding has been pushed back a year because completion of a manufacturing facility in Albany has been delayed.
The 10-year, 60 percent tax abatement on property improvements will now start in 2021 for tax year 2020. Construction is now slated to be completed by June 30 of this year.
The abatement change was approved Tuesday by the Athens County Commissioners.
Company founder and President Ed Zatta told the commissioners that contractor issues have put the project a year behind schedule.
RXQ Compounding is a maker of sterile pharmaceuticals and currently operates out of the Ohio University Innovation Center.
“We’re up to 74 employees right now at the old location,” Zatta told the commissioners. In February 2018, Zatta told The Messenger that RXQ had 37 employees.
He said Tuesday that the company will need to build or lease additional office space.
Zatta said the company currently works 10-hour shifts. “We’re going to work in there from 8 in the morning to 11 at night at the old facility to meet the demand,” Zatta said.
RXQ has also acquired Triangle Compounding in Cary, North Carolina.
“We brought all their business up here from Cary,” Zatta said.
RXQ has secured its first major hospital commitment involving hospitals in North and South Carolina and a couple in Georgia, and is expecting to be awarded its first Veterans Administration contract, according to Zatta.
“Those two more than double our sales in the next six months,” Zatta told the commissioners. Additional hospitals are expected to be added as customers when the move is made to the new facility.
“It sounds like there’s always bumps in the road, but a lot of good things are going your way,” Commissioner Chris Chmiel told Zatta.
Article from https://www.athensmessenger.com/news/rxq-construction-project-delayed-tax-abatement-extended/article_91606f30-70df-59a8-bf56-12277580cb0f.html?fbclid=IwAR1oRd_Y-4dCPRIbvevqf-jOLsj8luhPMVQ8LIEOC_GTVwlQtrLHju4CoTk
For a limited time, Ondansetron vials are 33% off. Order today and SAVE 33% on the following two products: Ondansetron 2 mg/ml 2 ml vial PFV with BUD date of 3/12/19 and Ondansetron 2 mg/ml 20 ml vial MDV with BUD date of 3/12/19. Contact your Sales Representative at (866) 280-0031 for a price quote today. Minimum amount to receive this discount is 5 vials. To redeem this deal, you must mention or write the following code with your order: 33OFF. Please call 866-280-0031 to place an order today!
02-06-2019 – For a limited time ONLY… Sodium Bicarbonate 8.4% 50 ml PFV vials with a BUD date of 3/31/2019 are being deeply discounted to $12.95 per vial. Minimum amount to receive this discount is 5 vials. To redeem this deal, you must mention or write the following code with your order: BICARB4.
02-05-2019 – RXQ has your #glutathione needs covered. On Friday, the Federal Drug Administration (FDA) warned facilities against using glutathione-L-reduced powder distributed by Letco Medical. This warning was made due to reported adverse effects and concerns with use of their distributed glutathione to compound injectable drugs due to potential endotoxins.
Seven individuals who received 200 mg/ml intravenous injections experienced side effects such a nausea, vomiting, and/or difficulty breathing. One patient was hospitalized immediately.
We would like to let all of our customers know the importance of choosing #RXQ Compounding, LLC as your supplier. As a 503B Outsourcing Facility, RXQ Compounding, LLC is required to follow strict testing standards for sterility, potency, and endotoxins developed by the FDA. RXQ utilizes third party testing for a full evaluation of stability indicating data and end product testing with all batches. Our testing would have discovered Letco’s endotoxin levels before any product left our facility.
RXQ Compounding, LLC did NOT source its glutathione powder from Letco Medical and we have Glutathione available for shipment today. Our available products are Glutathione 200 mg/ml 10 ml vial PFV and Glutathione 200 mg/ml 30 ml vial MDV. Our products offer you and your patients’ superior safety, availability, and compliance.
Please contact us at 866-280-0031 for information on how to order and pricing and please pass this information along to other individuals you know that may be affected during this time.
For more information regarding the FDA announcement, visit https://bit.ly/2D1VU3Z
02-01-2019 – “The #FDA is warning compounders not to use glutathione-L-reduced powder distributed by Letco Medical, Decatur, Alabama, to compound sterile injectable drugs for patients. Based on reported adverse events, the agency has concerns with use of the Letco distributed #glutathione to compound injectable drugs due to potential endotoxins.”
RXQ Compounding, LLC does not use glutathione powder from Letco Medical and we are here to cover your needs during this time. Please call 866-280-0031 to speak with a representative. For more information regarding this announcement, visit https://bit.ly/2D1VU3Z.
Founded in 2014 by local pharmacist and businessman Ed Zatta, who is President of the company, RXQ Compounding has grown from its beginning in a 500 square foot office where Zatta was the lone employee to the 40,000 square foot facility currently under construction.
RXQ Compounding, LLC, is an FDA-approved 503B outsourcing facility, which manufactures sterile and non-sterile medications including products that are on the FDA Short List. RXQ Compounding provides these medications to physician offices and hospitals across the United States in various sized vials and syringes. Zatta explained that the company takes raw material and processes it, as well as taking large amounts of materials and breaking it down into smaller units for use in hospitals.
Zatta stated that the company currently has 49 full-time equivalent employees as it operates out of the Ohio University Innovation Center, with that number expected to be around 100 in the next six months as the company prepares to move into its new facility.
The company employs individuals in a variety of roles, including, packing and shipping, technicians, sales, and pharmacists. Technicians are able to be trained by the company for their positions. Currently their are three pharmacists, with three more expected to be hired in the coming months.
RXQ Compounding handles the process from start to finish, taking the product from raw material to finished product, selling the product, and shipping it to the buyers.
At its current location, RXQ Compounding ships to 38 states, with the plan to increase to all states once the move is made to the new facility.
The new facility will allow for an increase in the volume of current products, as well as the expansion into new product lines.
Following his own investment in 2014, Zatta saw financial backing from a few friends, with recent multi-million dollar investments made in the company from the Ohio Innovation Fund and Advantage Capital.
In the past year, Zatta stated that they have raised a little over $9.5 million, which is all being invested into the facility in Albany. While a 40,000 square foot facility is currently being constructed, there is room for future expansion with an additional nine acres of property at the site.
In a news release, Advantage Capital recently announced its $3.6 million investment in the company.
The investment, including $1 million in equity under the Ohio Rural Business Growth (RBG) program, will help RXQ expand its new Albany manufacturing facility, increase research and development, and create as many as 100 jobs, stated the news release.
According to Advantage Capital, compounding facilities are one of the fastest growing areas in the healthcare industry, due to the rise of chronic diseases and increasing need from patients that cannot be treated with mass-produced FDA-approved medications. In 2002, less than 20 percent of hospitals elected to outsource any compounding needs. By 2017, 75 percent of hospitals were outsourcing these needs, and demand continues to grow.
“We are excited to expand our portfolio in Ohio and help move the state’s economy forward through innovation, business expansion and job creation. With RXQ, we utilized our full toolkit of investment capabilities to support the company’s growth plans, and we applaud its success and commitment to creating local jobs,” said Chris Harris, senior vice president at Advantage Capital.
Along with the Ohio RBG program, the investment was also made in connection with the federal New Markets Tax Credit program. Both were designed to increase the flow of capital into disadvantaged communities, growing businesses and creating jobs and opportunity in areas where access to capital and private investment is hard to find.
“By partnering with state and federal economic development programs, we’re able to provide both cost-effective debt capital and flexible, long-term equity capital to meet the unique needs of companies like RXQ. We are excited to replicate this investment model in support of other rural businesses across Ohio that need growth capital,” said Harris.
In addition to RXQ Compounding, Zatta has four pharmacies including Swisher and Lohse in Pomeroy, Ravenswood Drug, The Drugstore at O’Bleness and The Drugstore at OU.
For more information on RXQ Compounding visit rxqcompounding.com.
A portion of the information for this article provided by Advantage Capital.
08-29-2018 – Check us out on www.fortune.com at http://fortune.com/2018/08/27/term-sheet-monday-august-27/: “RXQ Compounding LLC, an Athens, Ohio-based outsourcing facility that produces medical formularies and medications, raised ~$3.6 million in funding Advantage Capital.”
08-23-2018 – Advantage Capital Invests in Ohio-Based RXQ Compounding, LLC – RXQ looks to create as many as 100 jobs in rural Ohio, highlighting significant economic impact of the Ohio Rural Business Growth Program.
Advantage Capital today announced a nearly $3.6 million investment in RXQ Compounding, LLC, an FDA-approved outsourcing facility that manufactures medical formularies and medications used in physician offices and hospitals across the country, located in Athens County, one of Ohio’s hardest hit rural areas.
The investment, including $1 million in equity under the Ohio Rural Business Growth (RBG) program, will help RXQ expand its new Albany manufacturing facility, increase research and development, and create as many as 100 jobs. In an area where more than one in every four people is unemployed, job creation of this magnitude shows the significant impact the RBG program will have on Ohio’s rural communities. Click here to view the whole article: http://www.investorpoint.com/news/MARKCOMM/7553952230491738/?utm_source=The+Brief+list&utm_campaign=c9b956a81a-EMAIL_CAMPAIGN_2018_08_24_09_58&utm_medium=email&utm_term=0_b3777c56e4-c9b956a81a-42256717.
07-23-2018 – Ohio Innovation Fund leads $7M round in Athens drugmaker – A pharmaceutical maker addressing critical drug shortages will fledge from an Ohio University incubator and add as many as 100 jobs in rural Athens County after closing a $7 million funding round. Click here for the full article: https://www.bizjournals.com/columbus/news/2018/07/23/ohio-innovation-fund-leads-7m-round-in-athens.html.
07-23-2018 – RXQ Compounding Secures Series A Funding Led by Ohio Innovation Fund – RXQ Compounding, LLC, a manufacturer of sterile and non-sterile medications licensed to ship to 38 states and Washington, D.C., today announced it has secured its Series A funding, led by Ohio Innovation Fund (OIF). RXQ will use the funds to open a new state-of-the-art FDA 503B outsourcing facility for pharmacy compounding, employing hundreds in the Appalachian area of Southeast Ohio.
“This investment will help RXQ open a new world-class compounding facility, boosting our ability to further serve our customers and expand our line of products,” said Ed Zatta, Chief Executive Officer of RXQ Compounding. “We’re excited to be supported by OIF, which has a proven track record in the region, including multiple IPOs and major acquisitions in both the technology and medical technology industries.” Click here to view the full article: https://globenewswire.com/news-release/2018/07/23/1540640/0/en/RXQ-Compounding-Secures-Series-A-Funding-Led-by-Ohio-Innovation-Fund.html.
Take a moment to listen to this Spectrum by WOUB Public Media podcast featuring Edward Zatta, Founder and President of RXQ Compounding, LLC. This podcast is brought to you by the Scripp’s College of Communication at Ohio University and discusses the subject, “How Safe are Your Compounded Drugs? Safer Since FDA Involvement.” Click here to listen now: http://apple.co/2q7K050.
Aug 27, 2017-Athens Business Poised for Expansion, Job Creation-By Steve Robb, Staff Journalist, The Athens Messenger.
A business in the Ohio University Innovation Center is planning a major expansion that would move the company to its own facility and create about 75 additional jobs.
RXQ Compounding, a company that makes sterile drugs for hospitals and physicians, is planning a $3.5-$4 million expansion, according to founder and President Edward Zatta.
“We’re getting ready to purchase a building from OhioHealth out in Albany,” Zatta explained, with additional space to be constructed. “We’re going to have about a 35,000-square-foot manufacturing facility there.”
The building in Albany, located on Blizzard Lane, was originally built as a physician’s office for OhioHealth and was later leased to Holzer Health System. Also, OhioHealth had some administrative and billing personnel there until they were moved to Athens, said Mark Seckinger, president of OhioHealth O’Bleness Hospital. He said closing of the sale should take place soon, although he declined to confirm that RXQ was the potential buyer.
Plans call for RXQ Compounding to construct a new compounding building and a shipping/receiving building. Even with that construction, Zatta said, there will be land remaining. Zatta explained that the plan is to first move RXQ’s administrative offices into the purchased building, with the new manufacturing space ready for use the second quarter of 2018. He said the company currently uses two clean rooms with three separate work areas at the Innovation Center, and the expansion is slated to have 14 work areas.
Zatta said the company has 22 employees, and that number is expected to increase to around 100 over a three-year period.
He said he hopes to get confirmation in the next few days that JobsOhio will help finance the expansion. “Our goal here is to keep generating jobs and keep growing, and try to find other opportunities to do that,” Zatta said. The company has been manufacturing in the Innovation Center for over two years, but that only started after working through a lengthy regulatory process, according to Zatta. “It’s a very regulatory-intensive type of industry,” he explained.
Zatta, who owns four pharmacies that include two in Athens at the Castrop Center and Ohio University, said the idea for RXQ Compounding grew out of an Ohio Pharmacists Association meeting in 2014 at which an attorney explained how new FDA regulations would impact compounding done by pharmacies. The new rules allowed for creation of compounding outsourcing facilities. Zatta said he approached the attorney for help in creating one, which led to formation of RXQ Compounding.
When asked for an example of what RXQ produces, Zatta mentioned that there is a nationwide shortage of injectable sodium bicarbonate, which is baking soda.
“We make sodium bicarb for hospitals to use. This is a drug that doesn’t sound like this great wonder drug, but it’s on every crash cart in every hospital if you need it…,” Zatta said, adding that there are other medical uses for it. Currently, RXQ is licensed in 33 states to sell its projects, according to Zatta.
There have been preliminary discussions about the Athens County Port Authority possibly issuing tax-exemption bonds for RXQ expansion, although Zatta said it would be for a future expansion beyond the one currently planned. Sara Marrs-Maxfield, secretary for the Port Authority and executive director of the Athens County Economic Development Council, said the Port Authority board hasn’t heard details of what RXQ would do with the bond financing if it is issued. She said Zatta will likely make a presentation to the board next month.
Zatta said the company plans to stay in Athens County long term.
“We’re actually trying to create jobs, we’re not just here having a business that’s going to go off to some investment banker and be transferred away from here,” he said. “RXQ is going to be here in the foreseeable future … We’re going to be in the Athens area in perpetuity.”
#RXQ #The503BDifference #503BOutsourcingFacility