October and November 2004 Lot of Neurontin Recalled
Apr 24, 2005 - 7:53:00 AM
Patients should not stop taking Neurontin before consulting with their physician. If they filled a prescription for the product in 100 mg strength between October 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.
By Pfizer Inc, [RxPG] Pfizer Inc voluntarily recalled one lot (40,000 bottles) of 100 mg capsules of its epilepsy medication, Neurontin, after a manufacturing mechanical failure resulted in some bottles containing empty or partially filled capsules.
Pfizer said only 100 mg strength capsules from lot #15224V --distributed in October and November 2004 -- are included in the recall. The production lot was distributed only in the United States. No other Neurontin lots were affected.
The company said it is possible that patients taking Neurontin to control epilepsy could experience seizures from a missed dose of the product.
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.
The company has worked closely with the FDA throughout the recall process. Patients should not stop taking Neurontin before consulting with their physician. If they filled a prescription for the product in 100 mg strength between October 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.
If consumers have questions about the recall, they should contact Pfizer Medical Information at 1-800-438-1985.
Pfizer said the recall of the affected lot will not result in a shortage of Neurontin 100 mg capsules.
Publication:
U.S. Food and Drug Administration (FDA)
On the web:www.pfizer.com
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