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Baxter International 52 articles

Baxter expands recall of intravenous heart drug

Baxter International is expanding a November 2017 recall of the heart drug Nexterone due to the presence of particle matter found floating in bags of the solution. If a patient receives an intravenous dose of a solution containing sterile particulate matter, he could experience adverse health reactions, the extent and severity of which depends on the size, number and composition of the foreign material and the patient’s underlying medical condition. “In the absence of in-line filtration,” the company said in a news release, “these particles may cause local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, phlebitis, pulmonary ... Read More

IV bag shortage worsened by nasty flu season

Ongoing shortages of saline and nutrient solutions from storm-ravaged Puerto Rico have taken a toll during this particularly nasty flu season, leaving hospital officials worried that if the supply of medicine and treatments for dehydrated patients with the flu doesn’t rebound soon, “more people are going to die,” said Deborah Pasko, director of medication safety and quality at the American Society of Health System Pharmacists. “I see it as a crisis.” Hurricane Maria tore through the U.S. territory of Puerto Rico in late September, cutting off power and limiting water supply. It also gravely affected drug makers with manufacturing plants ... Read More

Baxter recalls intravenous heart drug

Baxter International Inc., is recalling one lot of the heart medication Nexterone (amiodarone) after the company discovered particles floating in the solution during a stability study. The particulate was identified as consistent with polyethylene, the primary constituent of the film and ports used to manufacture the bag in which Nexterone is packaged. The matter is believed to have entered the solution during the manufacturing process. Intravenous administration of a solution containing sterile particulate matter may cause adverse health consequences, the extent and severity of which depends on the size, number, and composition of the foreign matter and the patient’s underlying ... Read More

IV nutritional supplement recalled

Baxter International Inc., is recalling one shipment from a single lot of the intravenous nutritional supplement Intralipid 20% IV Fat Emulsion distributed from Aug. 8 to Aug. 31, 2017, to hospitals and health care providers because the product has been exposed to subfreezing temperatures during transit to a distribution facility, the Food and Drug Administration announced in a Recall Notice. If Intralipid 20% IV Fat Emulsion is accidentally frozen, the emulsion droplets will increase in size and form aggregates that can block pulmonary circulation and lead to serious adverse health consequences that can be life-threatening. To date, Baxter has not ... Read More

Baxter solution recalled after insect found floating in bottle

Baxter International is recalling one lot of Sodium Chloride Irrigation after a customer complained about seeing an insect floating in the solution. Foreign matter contamination of an irrigation solution could potentially result in a series of complications dependent on which anatomic location the irrigation is used. Adverse effects include inflammatory reactions, foreign body reactions, and infections, all of which could be life threatening. No adverse events related to this recall have been reported to date. The recall includes one lot of 0.9 % Sodium Chloride Irrigation, USP, 500 mL Plastic Pour Bottle solution, an isotonic solution intended for irrigation such ... Read More

Drug maker Baxter plagued with numerous recalls in 2015

When Jose Almedia took over as CEO of Baxter International the first week of 2016, the company had just issued its latest recall. This one involved the intravenous solutions sodium chloride and dextrose, used to increase caloric intake and hydration in patients, due to a customer complaint that an insect was found floating in the solution. But this was just the latest woe for the Deerfield, Ill., maker of hospital and renal products. Baxter has been swamped with numerous  quality control issues resulting in recalls throughout 2015: Fifteen lots of IV solutions due to presence of particulate in the solutions that ... Read More

Bugs seen floating in Baxter IV solutions

Baxter International is recalling two lots of intravenous (IV) solutions used to replenish electrolytes and caloric supply in patients because of a confirmed customer complaint of an insect floating in bags of the solution. Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels, which can result in stroke, heart attack or damage to other organs such as the kidneys or liver. There is also the possibility of allergic reactions, local irritation and inflammation in tissues and organs. The recall involves 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container and ... Read More

Baxter recalls sodium chloride electrolyte solutions

Baxter International, Inc., is recalling two lots of 0.9 % Sodium Chloride injection in 100 mL MINI-BAG PLUS containers after two complaints of particles floating in vials. The particulate has been identified as a fragment from the vial adapter. The intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. The extent and severity of harm depends on the size, number, and composition of the foreign material and the patient’s underlying medical condition. Without in-line filtration, particles may cause local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolism (blockage of ... Read More

Injection to treat potassium deficiency recalled due to labeling error

Baxter International Inc., is recalling one lot of highly concentrated potassium chloride injection to treat potassium deficiency in patients because some containers are mislabeled as being of a higher concentration that the solution inside. If a lower than intended dose of potassium chloride is administered to high-risk patients prone to severe electrolyte imbalance, the results can be serious and life threatening. The recall involves one lot of Highly Concentrated Potassium Chloride Injection 10mEq per 100mL. Some containers of Product Code 2B0826, Lot Number P319160, Exp. 06/30/2015, NDC 0338-0709-48 were incorrectly labeled on the overpouch as Highly Concentrated Potassium Chloride Injection ... Read More

FDA recalls potassium chloride injection due to labeling error

Baxter International, Inc., is recalling one lot of potassium chloride injection because the drug packaging may contain units of gentamicin sulfate instead. Potassium chloride injection is used to treat potassium deficiency. Gentamicin sulfate is an antibacterial drug. This labeling error could result in a medication error or delay in therapy for patients who require high concentration of potassium chloride, the Food and Drug Administration (FDA) warned. The recall involves Lot #P318220, NDC # 0338-079-48 of potassium chloride Injection 10mEq per 100mL, with the product code 2B0826. Shipping cartons labeled for this specific lot number of potassium chloride injection may contain units ... Read More