Heart medication recalled after a dangerous mixture of labels, the FDA warns
The pills are incorrectly labeled and can have serious health consequences.
When you Get your prescription From the pharmacy, it comes with clear instructions on the quantity to be taken and when. Your pharmacist asks you even if you have any questions before you go home. In general, you also trust that your doctor has prescribed the right dose, you probably do not think of revealing the physical tablets or capsules given to you. However, errors occur, and now the Food and Drug Administration of the United States (FDA) announces a recall of cardiac drugs due to a confusion of label and resulting dosage problems. Read more to find out why the agency wants you to stop taking certain tablets immediately.
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The heart medication is recalled.
In a August 31 Press release , the FDA has announced that Marlex Pharmaceuticals, Inc. voluntarily remembers a batch of 0.125 USP Digoxine tablets and a batch of 0.25 Milligram USP Digoxine tablets.
The drug has been distributed nationally and is prescribed to treat mild to moderate heart failure, according to the FDA. The drug increases heart muscle contractions for pediatric patients with heart failure, and controls the ventricular response rate in adults with chronic atrial fibrillation, commonly known as AFIB.
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The two products were mixed.
According to the FDA, the products recalled have been poorly labeled. The packages for the 0.125 milligram Digoxine tablets actually contain tablets of 0.25 milligrams, while the packages for 0.25 milligram tablets contain the 0.125 milligram tablets.
"The mixture in the labels can cause overdose or a subdosis in patients who without knowing the poor dose," the statement said.
Those who take the larger dose but are supposed to take the tablets of 0.125 milligram at the FDA.
On the other hand, those who take the smaller dose but are supposed to take the 0.25 milligram tablets These patients may not have adequate medications to control their heart rate, leading to potential heart failure.
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Stop taking pills recalled if you have them at home.
As of August 31, Marlex Pharmaceuticals had not received reports of adverse events related to the recall, but the FDA still advises anyone with the tablets to stop using them and returning them to their place of purchase. Marlex also informs distributors and customers by e-mail to inform them of the recall and organize the return of affected products. AE0FCC31AE342FD3A1346EBB1F342FCB
If you take Digoxine tablets, take a look at your pharmacy cabinet. You should be able to say which dose you have when looking at the pills, which are two different colors.
The smaller dose tablets (0.125 milligrams) are "yellow, circular, bevelled, unwelcome" and marked in the middle. On the one hand of the pill, they have "n" and "201" on each side of the score, while the other side is clear. The larger dose tablets (0.25 milligrams) are in the same shape but "white to white". They are also marked on one side, with "N" and "202" on each side of the score brand.
The 0.125 milligram -recalled tablets have a large number of E3810s and an expiration date of February 2025 (2/2025). Digoxine tablets of 0.25 milligrams recalled also have a date of expiration February 2025, but their lot number is E3811. The two drugs came in packages of 100.
Call your doctor if you take this medication and have health problems.
If you encounter problems related to these drugs, the FDA asks you to contact your doctor or health care provider. In addition, if you feel an undesirable reaction, report it to the program of MEDWatch adverse events from the agency online ,, by email , or by fax.
For questions about the recall, you can reach Marlex Pharmaceuticals by phone at 302-328-3355, or free of charge at 888-582-1953, Monday to Friday, between 8:30 a.m. and 4:30 p.m. Is is).
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