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SafetyAlerts
June 1, 2001

Pfizer Recalls Fastmelt Benadryl Products to Correct Labeling Error

Morris Plains, NJ (SafetyAlerts) - Pfizer Inc is recalling Benadryl┬« Allergy & Sinus FastmeltTM and Benadryl┬« Children's Allergy/Cold FastmeltTM tablets.

The action was taken to alert people with a rare inherited metabolic condition known as phenylketonuria (PKU), who must control their intake of phenylalanine. The Benadryl Fastmelt label incorrectly states the amount of phenylalanine, which is contained in the common artificial sweetener aspartame, an inactive ingredient in the Fastmelt products. The correct amount of phenylalanine in both Fastmelt products is 4.6 mg per tablet, which is higher than the amount shown on the label. For people who do not have PKU, the Fastmelt labeling error does not raise this concern.

This recall does not affect any Benadryl medicines other than Benadryl Fastmelt.

The National Institutes of Health estimates that one in 15,000 people is born with PKU.

Pfizer recommends that people with PKU take note of the correct milligram content of phenylalanine in Benadryl Fastmelt products (4.6 mg per tablet). For those consumers who have purchased a Fastmelt product and do not wish to use it, Pfizer will replace it with a comparable Benadryl product or issue a full refund.

Pfizer has informed the U.S. Food and Drug Administration of this recall. Pfizer also is contacting the leading PKU organizations nationwide in an effort to communicate the correct information.

People with PKU seeking additional information may call the National Coalition for PKU and Allied Disorders at 1 877 996-2723, or visit the Coalition's website at www.pku-allieddisorders.org. Consumers seeking more information about Benadryl Fastmelt products and this recall may visit www.prodhelp.com; or call 1 800 524-2624 daily between 9 a.m. and 5 p.m. (Eastern Daylight Time).

Notice of this product warning was sent via email to SafetyAlerts subscribers June 1, 2001.  For more information regarding the SafetyAlerts free email alert service please click here.

Questions & Answers

What is Fastmelt?

Fastmelt is a quick-dissolve version of Benadryl.

How do I know if my Benadryl is Fastmelt?

The word "Fastmelt" is prominently displayed on the package.

What should people do with the product?

The product formulation is correct; only the labeling is incorrect. People without PKU, a rare metabolic condition, can continue to use the Fastmelt product. People with PKU should be aware that each tablet contains 4.6 mg of phenylalanine. If they are concerned, they should contact their doctor. The can also contact the National Coalition for PKU and Allied Disorders at 1-877-996-2723; www.pku-allieddisorders.org.

Anyone who does not wish to use the product should contact the Benadryl customer service department through 1-800-524-2624 for a full refund or replacement with a comparable Benadryl product.

Who is affected?

The labeling error may be of concern to people who have the rare inherited metabolic disease Phenylketonuria (PKU). These individuals must closely monitor phenylalanine intake, a naturally occurring amino acid.

How do people get more information?

For more information on Benadryl, consumers can call 1-800-524-2624 or visit www.prodhelp.com.

For more information on PKU, people should speak to their doctors. They also can contact the National Coalition for PKU and Allied Disorders at 1-877-996-2723 or visit www.pku-allieddisorders.org.

What is phenylalanine?

Phenylalanine is a naturally occurring essential amino acid. It is contained in the common artificial sweetener aspartame, which is an inactive ingredient in Fastmelts.

How are you communicating to the PKU population?

We are working through national PKU organizations to notify their members of the recall. We are also posting this information on PKU-related websites.

How do people know if they have PKU?

Since the mid-1960's, newborn screening for PKU has been conducted in every state in the United States and in many other countries. If a person has not been diagnosed with this condition, it is highly unlikely that the person is affected.

Is Benadryl Fastmelt safe?

Yes. The product formulation is correct; only the labeling is incorrect. However consumers who have the rare inherited metabolic disease Phenylketonuria (PKU) need to be aware of this labeling error since they must closely monitor their phenylalanine intake.

Is phenylalanine in any other Benadryl products?

Phenylalanine is present in the Benadryl chewables. Packaging for this product accurately reflects the phenylalanine content.

 
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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.