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Pfizer Recalls Epilepsy Drug

Factory Defect Left Some Capsules Short Of Medicine

Apr 23, 2005 | The Day

Pfizer Inc. has voluntarily recalled 40,000 bottles of its Neurontin epilepsy medication after a manufacturing malfunction caused some of the bottles to contain either empty or partially filled capsules.

Pfizer said it is possible that patients taking Neurontin to control their epilepsy could experience seizures from a missed dose of the product from one of the empty or partially filled capsules.

Pfizer said Friday that only 100-milligram capsules were affected from a specific lot 15224V distributed in October and November of this past year. Pfizer initially notified pharmacists and its distributors of the recall on Feb. 23. The company issued a press release on Friday as a follow-up to its initial recall.

The New York-based Pfizer, which employs about 6,500 in southeastern Connecticut, also encouraged pharmacists to immediately contact any of their customers using Neurontin to ensure their full awareness of the problem with the one lot of drugs that was distributed only in the United States.

Pfizer officials have been working closely with federal Food and Drug Administration officials throughout the recall process. The company said patients should not stop taking Neurontin before consulting with their physicians.

Neurontin has been approved by the FDA for treatment of partial seizures in adults and children and the drug also is approved for management of the pain that can last one to three months after a patient has shingles. The drug is available in various dosage forms, including tablets, capsules and liquid. During the first quarter of this year, Pfizer said the drug had worldwide sales of $182 million, down significantly from its first-quarter sales in 2004 of $696 million. The drug is one of several Pfizer drugs that have lost their patent exclusivity and now face increasing generic competition.

Pfizer said patients should contact their pharmacists if they believe their prescription for Neurontin was filled between Oct. 1, 2004 and March 15, 2005. In addition, consumers with questions about the recall should call Pfizer at 1-800-438-1985. Pfizer said the recall of the 40,000 bottles of Neurontin would not result in any shortages for the central-nervous system drug.

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