Otsuka Pharmaceutical Factory, Inc.

The recall, which was triggered by a customer complaint, covers two batches of the injection bags. After striking a pact to bolster intravenous solution supplies in the U.S. last year, California's ICU Medical has run into a snag during production of one such critical hospital drug.ICU Medical has recalled two lots of potassium chloride intravenous bags, citing a labeling problem that could lead users to overdose on the IV solution, according to an FDA notice posted Friday. Potassium chloride solution is used to rapidly restore potassium levels in patients with hypokalemia.The recall, which was triggered by a customer complaint, covers two batches of the injection bags with overwrap labels reading 10 mEq (mass per milliequivalent). The lots in question were packaged in cases marked as 20 mEq. The company blamed the problem on a "manufacturing issue," noting that while the 20 mEq bags are correctly labeled, the improper 10 mEq overwraps may obscure the accurate dose information. “If the Health Care provider mistakenly calculates the patient dose using 10 mEq, the patient will receive an overdose of potassium chloride,” the company warned in its release.The lots being recalled are numbered 1023172 with an expiration date of Jan. 31, 2026. Patients at particular risk of negative reactions to the wrong potassium chloride injection dose include premature infants or those on chronic parenteral nutrition, plus people with a history of cardiac arrhythmia, chronic renal insufficiency, acute renal failure, or those who are taking potassium-sparing diuretics, ICU Medical said.To date, there have been no reports of adverse events associated with the recall, the company added.ICU Medical's IV solution pull comes nearly two years after the company issued an FDA Class I recall of about 62,800 replacement batteries used in several of the company's infusion pumps, thanks in part to a manufacturing defect in some of the batteries that could lead them to run out of power more quickly than expected.  More recently, the company in November linked up with Otsuka's IV solutions subsidiary, Otsuka Pharmaceutical Factory, to help bolster supplies of intravenous hospital drugs in the U.S. The accord, which is expected to be operationally effective in the second quarter of 2025, was announced shortly after damage from Hurricane Helene forced Baxter International to temporarily close a massive IV fluids plant in North Carolina. 

The partnership features a $200 million up front payment from Otsuka to ICU, as well as other financial considerations. Otsuka’s IV solutions subsidiary, Otsuka Pharmaceutical Factory, is breaking into the North American market with the help of a new partner in ICU Medical. The two companies will join forces to bolster IV solution supply amid ongoing supply chain struggles.For the partnership, medical device maker ICU will join its North American production and distribution expertise, along with its IV pumps and consumables know-how, with Otsuka’s IV solution and manufacturing technology in use at 16 production sites across Asia. ICU will provide commercial services to allow for “seamless operations” for customers, the companies said in a joint press release (PDF). Otsuka will pay an upfront payment of approximately $200 million as well as performance-based milestones at the end of 2026 and other financial considerations in later years. The partnership should be operationally effective in the second quarter of 2025 and will form one of the largest global IV solutions manufacturing networks, producing an estimated 1.4 billion units annually, the companies said in the release. Over the long run, the companies aim to secure FDA approvals to bring IV solutions made at Otsuka's overseas sites to North America.“Entering the North American market has always been part of our long-term ambition, and this joint venture with ICU Medical is the perfect way to do that,” the Otsuka subsidiary’s president and representative director, Shuichi Takagi, said in the release.ICU Medical, meanwhile, considers Otsuka the “ideal partner” because of its scale, experience with U.S. partnerships and “demonstrated long-term investment horizon,” CEO Vivek Jain noted. U.S. IV solution supply continuity took a major hit this year when Hurricane Helene damaged Baxter International’s production site in Marion, North Carolina. Before the storm, the company supplied 60% of the United States' IV fluids, the Department of Health and Human Services said in a briefing. The damage prompted Baxter to initiate a sweeping importation plan that will bring nearly 18,000 tons of product from Europe and Asia to the U.S. by the end of the year.

Otsuka Pharmaceutical Factory is paying $200 million to the medical equipment company ICU Medical for an alliance to supply IV products to the US. The joint venture will have a combined capacity of 17 global manufacturing sites to provide roughly 1.4 billion units of IV drug products to the US market each year. It is expected to start from the second quarter of 2025, according to a Tuesday release. The two companies will also develop new IV drug products that ICU said have been historically hard to fund. ICU will promote any new drugs formed from the venture. “Entering the North American market has always been part of our long-term ambition, and this joint venture with ICU Medical is the perfect way to do that,” Otsuka Pharmaceutical Factory CEO Shuichi Takagi said. Based on performance, the company will pay ICU milestone payments at the end of 2026. Otsuka Pharmaceutical Factory, which has IV drug production sites across Asia, is a subsidiary of Otsuka Holdings. California-based ICU makes IV equipment products such as pumps and consumables. The partnership aims to create a long-term and resilient US supply chain for IV products, which has faced “persistent” challenges, ICU said during its third-quarter earnings presentation Tuesday. Baxter Healthcare, one of the biggest IV product suppliers in the US, had to temporarily close one of its manufacturing sites due to damage caused by Hurricane Helene in October. To mitigate shortages, Baxter pulled its IV products out of China to redirect supply to the US.