The FDA and drug company Pfizer have notified health care professionals of Pfizer's voluntary recall of one lot (40,000 bottles) of 100 milligram capsules of the epilepsy medication Neurontin.
Pfizer issued the recall after a mechanical failure in the manufacturing process resulted in some bottles containing empty or partially filled capsules, says a Pfizer news release dated April 22.
The recalled Neurontin capsules came from lot number 15224V, which was distributed in October and November 2004, says Pfizer.
The production lot was only distributed in the U.S. and no other Neurontin lots were affected, according to Pfizer. The company says the recall will not result in a shortage of Neurontin 100 milligram capsules.
Pfizer's Advice for Patients
"It is possible that patients taking Neurontin to control epilepsy could experience seizures from a missed dose of the product," says Pfizer's news release.
"Patients should not stop taking Neurontin before consulting with their physician," the news release continues. "If they filled a prescription for the product in 100 mg strength between Oct. 1, 2004 and March 15, 2005 and are concerned that any unused capsules may be part of the recalled lot, they should contact their pharmacist."
Previous Notification Issued to Pharmacists, Distributors
"Although pharmacists and Pfizer distributors were notified on February 23 of the recall and pharmacists were instructed to immediately contact any of their customers using Neurontin, Pfizer wants to ensure full patient awareness," says Pfizer's news release, adding that Pfizer "has worked closely with the FDA throughout the recall process."
The news release asks that customers call Pfizer's medical information line ((800) 438-1985) with any questions about the recall.
By Miranda Hitti, reviewed by Brunilda Nazario, MD
SOURCES: FDA Medwatch: "Neurontin (gabapentin)." News release, Pfizer.