- Data di annuncio della società:
- Febbraio 20, 2020
- Data di pubblicazione della FDA:
- Febbraio 21, 2020
- Tipo di prodotto:
- Motivo dell'annuncio:
Possible underdosing or overdosing
- Nome della ditta:
- Taro Pharmaceuticals USA, Inc.
Taro Pharmaceuticals USA, Inc.
- Descrizione del prodotto:
Phenytoin Oral Suspension USP, 125 mg/5 mL
Annuncio di società
Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling two (2) lots of Phenytoin Oral Suspension USP, 125 mg/5 mL both in 237 mL bottles, to the consumer level. Phenytoin Oral Suspension USP, 125 mg/5 mL is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and is packaged in amber plastic bottles with an inner seal and a white child proof closure, and each bottle contains 237 mL. The reason for the recall is that product from these two lots of Phenytoin Oral Suspension may not re-suspend when shaken, as instructed for administration, which could result in under or overdosing. This recall is being conducted with the knowledge of the FDA.
The population at risk is primarily infants and young children. In those patients, there is a reasonable probability that inaccurate dosing might result in a serious adverse effect such as intoxication or breakthrough seizures requiring medical intervention. For a small minority of patients, who might have severe or repeated breakthrough seizures, a drop in their phenytoin blood levels could result in life-threatening status epilepticus requiring immediate emergency room treatment. To date, Taro has not received any adverse event reports related to this recall. (More ...)