LAKE ZURICH, Ill.--(BUSINESS WIRE)--Nov 6, 2025--
Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies is voluntarily recalling three lots (numbers 6133156, 6133194, 6133388) of Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL vial. This recall is being performed to the user level in the United States.
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Three lots (numbers 6133156, 6133194, 6133388) of Famotidine Injection are being recalled in the U.S. by Fresenius Kabi.
Three lots (numbers 6133156, 6133194, 6133388) of Famotidine Injection are being recalled in the U.S. by Fresenius Kabi.
Three lots (numbers 6133156, 6133194, 6133388) of Famotidine Injection are being recalled in the U.S. by Fresenius Kabi.
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The product is being recalled due to out-of-specification (OOS) endotoxin results of certain reserve samples from a single lot. Based upon the investigation, two additional lots were also included in the recall as a precautionary measure.
Elevated endotoxin levels can precipitate severe systemic reactions such as sepsis and septic shock. Severe responses may include inflammatory and life-threatening immune responses and death. Non-serious adverse event reports potentially associated with the OOS have been received for one lot. These non-serious adverse events included chills, change in mental status, change in respiratory status, fever, increase in body temperature, shivering and shaking. To date, no adverse event reports have been received for the second and third lots.
Famotidine Injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or as an alternative to the oral dosage forms for short term use in patients who are unable to take oral medication for the following conditions:
Fresenius Kabi is notifying its distributors and customers and is arranging for return of the recalled product. If health care facilities have any of the affected lots, they are to immediately discontinue distributing, dispensing or using the lots and return all units to Fresenius Kabi. Distributors are instructed to immediately notify their customers that have been shipped or may have been shipped, the product involved in this recall.
Consumers with questions regarding this recall can contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time. Patients should contact their physician or health care provider if they have experienced any problems that may be related to receiving this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to Fresenius Kabi Medical Affairs or Vigilance departments at 1-800-551-7176, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time, or send an e-mail to either productcomplaint.USA@fresenius-kabi.com or adverse.events.USA@fresenius-kabi.com.
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.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
About Fresenius Kabi
As a global healthcare company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of patients with critical and chronic conditions. With more than 41,000 employees and present in more than 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies.
Three lots (numbers 6133156, 6133194, 6133388) of Famotidine Injection are being recalled in the U.S. by Fresenius Kabi.
Three lots (numbers 6133156, 6133194, 6133388) of Famotidine Injection are being recalled in the U.S. by Fresenius Kabi.
Three lots (numbers 6133156, 6133194, 6133388) of Famotidine Injection are being recalled in the U.S. by Fresenius Kabi.
DUBAI, United Arab Emirates (AP) — Iran fired more missiles at Israel and Gulf Arab states Thursday, demonstrating Tehran’s continued ability to strike its neighbors even as U.S. President Donald Trump claimed the threat from the country was nearly eliminated.
Iran’s attacks on Gulf states along with its chokehold on the Strait of Hormuz have disrupted the world’s energy supplies with effects far beyond the Middle East. That has proved to be Iran’s greatest strategic advantage in the war. Britain held a call with nearly three dozen countries about how to reopen the strait once the fighting is over.
Trump has insisted the strait can be taken by force — but said it is not up to the U.S. to do that. In an address to the American people Wednesday night, he encouraged countries that depend on oil from Hormuz to “build some delayed courage” and go “take it.”
Before the U.S. and Israel started the war on Feb. 28 with strikes on Iran, the waterway was open to traffic and 20% of all traded oil passed through it.
Iran responded defiantly to Trump’s speech, in which the American president claimed U.S. military action had been so decisive that “one of the most powerful countries” is “really no longer a threat.”
A spokesman for Iran’s military, Lt. Col. Ebrahim Zolfaghari, insisted Thursday that Tehran maintains hidden stockpiles of arms, munitions and production facilities. He said facilities targeted so far by U.S. strikes are “insignificant.”
Just before Trump began his address — in which he said U.S. “core strategic objectives are nearing completion” — explosions were heard in Dubai as air defenses worked to intercept an Iranian missile barrage.
Less than a half-hour after the president was done, Israel said its military was also working to intercept incoming missiles. Sirens sounded in Bahrain, home to the U.S. Navy’s 5th Fleet, immediately after the speech.
Attacks continued across Iran on Thursday, with strikes reported in multiple cities.
Trump posted footage on social media showing what he said was the collapse of Iran's biggest bridge and threatening, “Much more to follow.”
Earlier Thursday, Iran state media reported that the B1 bridge that’s under construction was attacked. Two semiofficial news agencies reported that two people were killed. It was not immediately clear if the footage Trump shared was the B1 bridge, reportedly the tallest in the Middle East.
Even amid the conflict, families went to a park in Tehran to play games and grill food to mark the last day of Iranian New Year, or Nowruz.
In Lebanon — where Israel has launched a ground invasion against Iran-backed Hezbollah militants — Israeli strikes have killed 27 people in the past 24 hours, the Health Ministry said.
More than 1,900 people have been killed in Iran during the war, while 19 have been reported dead in Israel. More than two dozen people have died in Gulf states and the occupied West Bank, while 13 U.S. service members have been killed.
More than 1,300 people have been killed and more than 1 million displaced in Lebanon. Ten Israeli soldiers have also died there.
Iranian attacks on about two dozen commercial ships, and the threat of more, have halted nearly all traffic in the waterway that connects the Persian Gulf to the open ocean.
Since March 1, traffic through the strait has dropped 94% over the same period last year, according to the Lloyds List Intelligence shipping data firm. Two ships are confirmed to have paid a fee, the firm said, while others were allowed through based on agreements with their home governments.
Saudi Arabia piped about 1 billion barrels of oil away from the Strait of Hormuz in March, according to maritime data firm Kpler, while Iraq said Thursday that it had started to truck oil across Syria to avoid the strait.
The 35 countries that spoke Thursday, including all G7 industrialized democracies except the U.S., as well as the United Arab Emirates and Bahrain, signed a declaration last month demanding Iran stop blocking the strait.
Thursday’s talks were focused on political and diplomatic measures, but British Foreign Secretary Yvette Cooper said military planners from an unspecified number of countries will also plot ways to ensure security once fighting ends, including potential mine-clearing work and “reassurance” for commercial shipping.
No country appears willing to try to open the strait by force while the war is raging. French President Emmanuel Macron, while on a visit to South Korea, called a military operation to secure the waterway “unrealistic.”
But there is a concern that Iran might limit traffic through the waterway even after U.S. and Israeli attacks cease.
The conflict is driving up prices for oil and natural gas, roiling stock markets, pushing up the cost of gasoline and threatening to make a range of goods, including food, more expensive.
On Thursday, Brent crude, the international standard, rose again and was around $108, up about 50% from Feb. 28.
Though the oil and gas that typically transits the strait is primarily sold to Asian nations, Japan and South Korea were the only two countries from the region joining Thursday's call about the strait. The supply of jet fuel has also been interrupted, with consequences for travel worldwide.
Rising from Bangkok and Corder reported from The Hague, Netherlands. Associated Press writers Will Weissert in Washington and David McHugh in Frankfurt, Germany, contributed to this story.
Israeli security forces and rescue teams inspect a site struck by an Iranian missile in Petah Tikva, Israel,Thursday, April 2, 2026. (AP Photo/Ohad Zwigenberg)
A boy who fled with his family following Israeli strikes in southern Lebanon sits inside the van they are using as shelter in Sidon, Lebanon, Thursday, April 2, 2026. (AP Photo/Emilio Morenatti)
A family enjoys their time during the annual public picnic day, known as Sizdeh Bedar, an ancient tradition, marking the 13th and last day of Iranian New Year, or Nowruz, holidays, at Mellat park in Tehran, Iran, Thursday, April 2, 2026. (AP Photo/Vahid Salemi)
Mourners gather during a funeral procession for Alireza Tangsiri, head of Iran's Islamic Revolutionary Guard Corps Navy, and others killed in Israeli strikes in late March, in Tehran, Iran, Wednesday, April 1, 2026. (AP Photo/Vahid Salemi)
A firefighter extinguishes a car at the site of Israeli airstrikes, in Beirut, Lebanon, Wednesday, April 1, 2026. (AP Photo/Hussein Malla)
People take cover in a bomb shelter as air raid sirens warn of incoming Iranian missile strikes in Bnei Brak, Israel, Wednesday, April 1, 2026. (AP Photo/Oded Balilty)
Members from the Popular Mobilization Forces attend a funeral of fighters who were killed in a U.S. airstrike, in Tal Afar, Nineveh province, north of Baghdad, Iraq, Thursday, April 2, 2026. (AP Photo/Hadi Mizban)
Members from the Popular Mobilization Forces attend a funeral of fighters who were killed in a U.S. airstrike, in Tal Afar, Nineveh province, north of Baghdad, Iraq, Thursday, April 2, 2026. (AP Photo/Hadi Mizban)
The Indian flagged LPG carrier Jag Vasant transporting liquefied petroleum gas, is seen at the Mumbai Port in Mumbai, India, after it arrived clearing the Strait of Hormuz, Wednesday, April 1, 2026. (AP Photo/Rafiq Maqbool)
President Donald Trump speaks about the Iran war from the Cross Hall of the White House on Wednesday, April 1, 2026, in Washington. (AP Photo/Alex Brandon, Pool)
President Donald Trump walks from the Blue Room to speak about the Iran war from the Cross Hall of the White House on Wednesday, April 1, 2026, in Washington. (AP Photo/Alex Brandon, Pool)
President Donald Trump speaks about the Iran war from the Cross Hall of the White House on Wednesday, April 1, 2026, in Washington. (AP Photo/Alex Brandon, Pool)
President Donald Trump speaks about the Iran war from the Cross Hall of the White House on Wednesday, April 1, 2026, in Washington. (AP Photo/Alex Brandon, Pool)
