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Medical Professionals Reference (MPR)Label Mix-Up Prompts Recall of Heart Failure Medication

Marlex Pharmaceuticals Recalls Digoxin Tablets Due to Label Mistake

In a recent development, Marlex Pharmaceuticals has initiated a recall for specific lots of its Digoxin Tablets, a medication used for treating heart failure and controlling ventricular response rate in atrial fibrillation. The recall is due to a labeling error that could result in patients receiving incorrect dosages, posing significant health risks.

HCN Medical Memo
Physicians should exercise extreme caution when prescribing or administering Digoxin to patients during this recall period. The label mix-up poses a serious risk of either super potent or sub potent dosing, which could lead to severe complications in heart failure and atrial fibrillation patients. Immediate steps should be taken to identify and replace any affected lots in your inventory.

Key Points:
  • Marlex Pharmaceuticals is recalling Digoxin Tablets 0.125mg (lot# E3810, expiration 2/2025) and 0.25mg (lot# E3811, expiration 2/2025).
  • The label mix-up involves bottles labeled with 0.125mg actually containing 0.25mg tablets and vice versa.
  • Digoxin is used for treating mild to moderate heart failure and controlling ventricular response rate in chronic atrial fibrillation.
  • Incorrect dosage due to the label mix-up could lead to significant adverse events, although no injuries have been reported so far.
  • Physicians are urged to report any adverse reactions related to this recall to the FDA’s MedWatch program.

According to the FDA, there were more than 4,400 drug and medical device recalls in the United States in 2019.

Additional Points:
  • Patients can differentiate the tablet strengths by their appearance: 0.125mg tablets are yellow and marked with “N” and “201,” while 0.25mg tablets are white to off-white and marked with “N” and “202.”
  • HCPs or consumers with with questions should contact Marlex Pharmaceuticals at 302-328-3355 or 888-582-1953.
  • The products were distributed nationwide.

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