Xellia Pharmaceuticals ApS

The company first initiated a voluntary recall at the retail level on July 8. After Hikma initiated a recall of one batch of acetaminophen injection earlier this month, the company is extending the nationwide recall to the consumer level. The company started the recall (PDF) due to the “potential presence” of a bag labeled dexmedetomidine HCL injection inside packaging labeled for acetaminophen injection, a pain med. Dexmedetomidine is a sedative often used before or during surgery. Accidental administration of dexmedetomidine instead of acetaminophen poses risks of “varying degrees” of sedation for patients, plus slowed breathing or heart rate, variable blood pressure and “potentially life-threatening outcomes,” Hikma warned in a release. So far, the manufacturer has received one report of an adverse event. The lot in question was manufactured in March and expires in September 2025. Hikma first asked its direct customers to remove the product from distribution on July 8 and is now extending the recall to the consumer level. The company requests that customers at medical facilities locate, remove and return the affected product. Acetaminophen injection is used to manage mild to moderate pain, reduce fever and quell moderate to severe pain alongside adjunctive opioid analgesics in patients 2 and older. The recalled intravenous infusion is sold in a 100mL bag of 1,000mg strength per 100 mL (10mg/mL). Meanwhile, London-based Hikma will soon have a new plant to develop, manufacture, pack and distribute its IV bag products after striking a deal worth up to $185 million with Xellia in June. The generic drugmaker will take on Xellia’s Cleveland-based facility and make processes upgrades within the next three years through an undisclosed investment.

Back in December, in a separate WARN alert, Xellia noted it would start cutting roughly 80 positions at the Bedford plant starting in February. Following last week’s news that generic drugmaker Hikma is acquiring parts of Xellia’s assets in the U.S., the Danish drugmaker has unveiled plans for a fresh round of layoffs. In connection with the sale of the company’s Bedford plant on the outskirts of Cleveland, Ohio, to Hikma, Xellia said it’s cutting 247 positions in the U.S. Of the affected staffers, 214 work at the Bedford facility, Xellia said in a Worker Adjustment and Retraining Notification (WARN) alert sent to the state. The round of cuts will kick off in August and cover multiple roles at the company, including analytical chemists, aseptic operators, automation engineers, IT technicians and managerial positions. The latest layoff round marks the second for Xellia this year. Back in December 2023, in a separate WARN alert, the company noted it would start cutting roughly 80 positions at the Bedford plant starting in February. News of last week’s staff cull follows London-based Hikma’s decision to shell out $135 million in cash and another $50 million in contingencies to snatch up parts of Xellia’s assets in the U.S., including its manufacturing facility in the Cleveland suburbs. The Bedford site features end-to-end capabilities to develop, manufacture, pack and distribute freeze-dried vials and aseptically filled ready-to-use IV bag products, according to Hikma’s release last week. Aside from the Bedford plant, Hikma is also getting its hands on a range of Xellia’s ready-to-use products like Vanco Ready (vancomycin), which is used to treat bacterial infections. Plus, the company is acquiring an R&D facility and its staff located in Zagreb, Croatia.

Generics maker Hikma will shell out up to $185 million to acquire parts of Xellia’s assets in the U.S., including the Danish drugmaker’s 24-acre manufacturing facility in Cleveland. Hikma, a London-based generics maker, has agreed to buy parts of Xellia’s assets in the U.S., including the Danish drugmaker’s manufacturing facility in Cleveland. Hikma will pay $135 million in cash with an additional $50 million going to Xellia based on contingencies, the company said in a June 17 press release. The deal is subject to approval from the U.S. Federal Trade Commission. Under terms of the transaction, Hikma gets the Cleveland facility that features end-to-end capabilities to develop, manufacture, pack and distribute lyophilized vials and aseptically filled ready-to-use IV bag products. The generic drugmaker revealed plans to invest an undisclosed amount into the facility to boost productivity by adding automation, equipment and updated processes. Hikma aims to complete the upgrades at the plant within the next three years. The facility could be used to establish an entry into the CDMO business in the future, the company said. “Hikma has grown to become a top-three U.S. supplier of sterile injectable medicines thanks to our strong record of successfully making value-enhancing acquisitions like this one,” Riad Mishlawi, Hikma’s chief executive, said in the release. “This acquisition will add significant scale to our U.S. operations and will enhance our U.S. injectable manufacturing capabilities and portfolio by adding complex technologies.” Hikma also gets a range of ready-to-use products from Xellia, including Vanco Ready (vancomycin) used to treat bacterial infections like methicillin-resistant Staphylococcus aureus (MRSA). Additionally, it picks up an R&D facility and its staff located in Zagreb, Croatia, with the deal. In 2022, Hikma entered the Canadian market with the $45.75 million purchase of assets of Taligent, which was under bankruptcy. That deal included 25 sterile injectable products, three in-licensed ophthalmic products and seven other products (four of them approved by Health Canada) that were in Teligent’s pipeline at the time.