Fresenius Kabi, a division of the global healthcare company Fresenius and a leading provider of essential medicines and medical technologies, has announced a voluntary nationwide recall of three specific lots of Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL fill in a 2 mL vial. The affected lot numbers are 6133156, 6133194, and 6133388, and the recall is being implemented at the user level across the United States.
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This recall follows the discovery of out-of-specification endotoxin levels in certain reserve samples from one lot, with two additional lots included as a precautionary measure. Elevated endotoxin levels can cause serious systemic reactions, including sepsis, septic shock, inflammatory responses, and in severe cases, death. To date, non-serious adverse events such as chills, fever, shivering, changes in mental status, and respiratory changes have been reported for one lot, while no adverse events have been reported for the other two lots.
Famotidine Injection is used for short-term treatment of active duodenal and benign gastric ulcers, maintenance therapy following ulcer healing, management of gastroesophageal reflux disease, and treatment of pathological hypersecretory conditions in hospitalized patients. It is also an alternative to oral forms for patients unable to take oral medications.
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Fresenius Kabi is contacting its distributors and customers and arranging the return of all affected products. Healthcare facilities are instructed to immediately stop distributing, dispensing, or using the recalled lots and return all units to Fresenius Kabi. Distributors must promptly inform their customers about the recall.
Patients with questions may contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459, Monday through Friday from 8 a.m. to 5 p.m. Central Standard Time. Any patients who have experienced health issues potentially related to the drug should contact their physician or healthcare provider for guidance.
This recall demonstrates Fresenius Kabi’s commitment to patient safety and maintaining the highest quality standards for its products.
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