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Once the final results from the manufacturer are received, FDA will conduct a comprehensive review and will update the public with any new information.
The febuxostat drug labels already carry a Warning and Precaution about cardiovascular events because the clinical trials conducted before approval showed a higher rate of heart-related problems in patients treated with febuxostat compared to allopurinol.
Dose-dependent serious cardiac arrhythmias may be observed with higher dosages of ondansetron in those patients with certain pre-existing cardiac conditions.
Patients may also be at risk for serotonin syndrome.
Patients should talk to your health care professionals if you have any questions or concerns.
Do not stop taking your medicine without first consulting with your health care professional.
Each 100 mg Activase vial (58 million IU) is packaged with diluent for reconstitution (100 m L Sterile Water for Injection, USP), and one transfer device: NDC 50242-085-27.
The product was distributed nationwide to hospitals.
The vials of Sterile Water for Injection, manufactured by Hospira Inc., a Pfizer company, and packaged with Activase 100 mg, may be cracked or chipped at the neck of the vial and leaking.See press release (https://gov/Safety/Recalls/ucm574980.htm) for affected lots.The use of impacted Sterile Water for Injection could result in adverse events such as fever, chills, phlebitis, and granuloma or more severe adverse events such as sepsis or invasive systemic infections.Consumers with questions regarding this recall can contact Fresenius Kabi Quality Assurance at 1-866-716-2459.Consumers should contact their physician or health care provider if they have experienced any problems that may be related to receiving this drug product.
If health care facilities have the affected lot, they are to immediately discontinue distributing, dispensing or using the lot and return all units to Fresenius Kabi.