WASHINGTON, D.C. — The U.S. Food and Drug Administration, or FDA, along with Taro Pharmaceuticals U.S.A., announced a voluntary recall for Phenytoin Oral Suspension USP, in the dose of 125 mg/5 ml because of the potential patients will receive an insufficient dose or could overdose. Taro recalled two lots of the drug, both of which were packed in 237 ml bottles according to the FDA announcement concerning the recall. Taro Pharmaceuticals indicated that the recalled medication might not “re-suspend” when shaken. Therefore, the medication will not be effective. The company said that that the FDA is aware of the recall program. The FDA oversees every medication recall program in the U.S.
Taro Pharmaceuticals manufactured Phenytoin Oral Suspension USP 125 mg/5 ml dose to help patients combat both grand mal and temporal lobe seizures. Neurologists refer to these seizures as tonic-clonic and psychomotor seizures, respectively. The instructions accompanying the oral solution indicates that the medication must be shaken before administered. The oral suspension might not re-suspend, and therefore the next dose could exceed the recommended dose, or the patient might not receive a sufficient dose.
The FDA indicated that the patients at the highest risk of injury from not receiving the correct dosage of Phenytoin. The young patient could suffer intoxication-like effects if the child receives an overly-potent dose. The child could also suffer from a breakthrough seizure if he or she receives an insufficient dose of Phenytoin Oral Suspension USP.
Some patients who experience severe breakthrough seizures and also experience a drop in their phenytoin levels in their blood could face a life-threatening status epilepticus (a condition that involves a continuous state of seizure) that requires immediate treatment in an emergency room. Despite these ominous side-effects of the faulty medication, Taro Pharmaceuticals claims that the company has not received any complaints about adverse incidents to any patients taking medicine.
The two lots recalled are numbered 327874 and 327876. Any patients who have these recalled lots must return them to their pharmacist immediately.
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