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Taro Pharma Recalls Certain Lots Of Phenytoin Oral Suspension

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Taro Pharmaceuticals U.S.A., Inc., the U.S.-based business of Israeli Pharma firm Taro Pharmaceutical Industries, Ltd., recalled certain lots of seizure medication Phenytoin in the form of oral suspension for potential underdosing or overdosing, the U.S. Food and Drug Administration said in a statement.

The company found that the oral suspension may not re-suspend when shaken, as instructed for administration, which could result in underdosing or overdosing.

The company is recalling two lots of Phenytoin Oral Suspension USP of 125 mg/5 mL mg strength that are packaged in 237 mL amber plastic bottles with an inner seal and a white child proof closure. The recalled lot bear numbers 327874 and 327876, both having expiration date of December 2020.

The lots were distributed to wholesale distributors, long-term care providers, a repackager and mail order customers in the U.S. market between May 3 and August 21, 2019.

Taro Pharma is yet to receive any reports of adverse events involving the recalled product.

The company warned that patients administered with this oral suspension, primarily infants and young children, could be at risk of serious adverse effect such as intoxication or breakthrough seizures requiring medical intervention due to the inaccurate dosing.

It could also result in life-threatening status epilepticus for a small minority of patients, who might have severe or repeated breakthrough seizures and a drop in their phenytoin blood levels, requiring immediate emergency room treatment.

Phenytoin Oral Suspension is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures in certain types of epilepsy.

The company urged retail customers that have any quantities of these two lots which are being recalled, to stop distribution and return any unsold units to their wholesaler.

In mid-January, Taro Pharmaceuticals had recalled a certain lot of epilepsy and bipolar disorder medication Lamotrigine in the form of tablets for the potential cross-contamination with a small amount of another drug substance, Enalapril Maleate, used to make another product at the same facility. Enalapril Maleate is a drug substance indicated for hypertension and congestive heart failure.

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