Voluntary Class I RECALL – Dispensing Level – Initiated 10/19/23 Exela Pharma Sciences, LLC Issues Voluntary Nationwide Recall of8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL, Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL, and ELCYS (cysteine hydrochloride Injection), USP 500 mg/10 mL due to the Presence of Particulate Matter Microsoft Word Doc
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BY NEWS-TOPIC STAFF LENOIR – The Exela Pharma Sciences Inpatient Pharmacy will be a part of UNC Health Caldwell’s planned $33+ million expansion, the hospital announced Friday. “We’re proud to be able to support our local hospital,” said Phanesh Koneru, founder and CEO of Exela Pharma Sciences. “The new inpatient pharmacy is very aligned with Exela’s focus on delivering excellence in quality and reliability.” Last renovated in 1983, the current inpatient pharmacy is undersized and lacks the equipment and space needed to provide the expanded scope of services UNC Health Caldwell offers today. “The pharmacy department has expanded services, regulations
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Lenoir, NC February 6, 2023 – Exela Pharma Sciences, LLC (“Exela”) has commenced patent infringement litigation today against Nivagen Pharmaceuticals, Inc. (“Nivagen”) in the United States District Court for the District of Delaware to prevent unauthorized launch of its recently approved 7.25% L-Cysteine injection drug product. Exela believes Nivagen’s product infringes one or more of Exela’s patents covering Exela’s pioneering work in developing low-aluminum L-Cysteine injection products. Exela seeks among other remedies a temporary restraining order and an injunction. About Exela Pharma SciencesExela Pharma Sciences, a fast-growing US based integrated specialty pharmaceutical company, focuses on developing, manufacturing and marketing proprietary
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Exela Pharma Sciences, LLC Expands Voluntary Nationwide Recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-Count Carton due to Vial Breakage UPDATED November 28, 2022
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Exela Pharma Sciences, LLC Issues Voluntary Nationwide Recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-Count Carton due to Vial Breakage
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PREMIER INC. and 11 Leading Health Systems Invest in EXELA Pharma Sciences to Secure and Support U.S. – Based Drug Supply and Manufacturing Drug shortages have long plagued U.S. healthcare providers; COVID-19 has compounded sourcing challenges New initiative will manufacture pharmaceutical products in North Carolina, primarily using APIs from the U.S. and Europe Media Contact:Premier – Noah Zachary212.901.1251Public_Relations@premierinc.com CHARLOTTE, N.C., September 8, 2021 ─ Premier Inc. (NASDAQ: PINC), a leading technology-driven healthcare improvement company, and 11 leading health systems acquired a minority stake in Exela Holdings, Inc., the holding company of Exela® Pharma Sciences, LLC, to secure vital supply of
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EXELA’s Position on Use of Our Products in Lethal Injections for Capital Punishment Exela Pharma Sciences believes that providing medicines to alleviate human pain and suffering is one of the noblest undertakings. Making medicines affordable and expediting their availability to the needy is a worthy goal. That is Exela®’s focus and Mission. Exela opposes any use of our products that does not meet our Mission Statement, including the use of Potassium Acetate for lethal injection in capital punishment cases. We have taken actions to ensure our products are only available to those health care providers that use the products for
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Lenoir, NC September 11, 2019 – Exela Pharma Sciences is pleased to announce the launch of Sodium Bicarbonate Injection, USP. Exela received approval of its ANDA for Sodium Bicarbonate Injection in May for four separate presentations. The first presentation to launch will be the 8.4% Sodium Bicarbonate Injection, 50mEq/50mL (1mEq/mL) vials. This product has been on the FDA Drug Shortage list consistently and we are excited to be only the second FDA Approved Sodium Bicarbonate Injection on the US market. Exela will introduce shortly three additional presentations: an 8.4%, 10mEq/10mL (1mEq/mL) vial; a 7.5%, 44.6mEq/50mL (0.9mEq/mL) vial; and a 4.2%,
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Lenoir, NC May 31, 2019 – Exela Pharma Sciences is pleased to announce the approval and immediate launch of ELCYS™ (cysteine hydrochloride injection), USP, the only FDA Approved cysteine hydrochloride injection on the market in the United States. ELCYS™ was approved under priority review as a New Drug Application (NDA). It is not an Abbreviated New Drug Application (ANDA) product. The NDA is the result of significant research and development aimed at lowering the Aluminum content in the drug product.   ELCYS™ is labeled to contain no more than 120 parts per billion (mcg/L) of Aluminum. ELCYS™ is indicated for use
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