Lableling Error Forces Recall of TWo Benadrly Products

June 9, 2001

Labeling Error Forces Recall of Two Benadryl Products

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WASHINGTON (Reuters Health) Jun 04 - Pfizer Inc. initiated on Friday a

voluntary recall of two over-the-counter (OTC) drugs due to a labeling error

that misstated the amount of an active ingredient, a mistake that could pose a

risk to people with a rare metabolic disorder.

The products recalled were the company's Benadryl Allergy and Sinus

Fastmelt and its Benadryl Children's Allergy/Cold Fastmelt tablets. The recall

encompasses all 50 US states as well as Puerto Rico.

According to Pfizer, the recall was initiated because these products

contain 4.6 mg of phenylalanine per tablet, but the label incorrectly stated a

lower amount. At those levels, the company added, phenylalanine could pose a

danger to people with phenylketonuria.

Pfizer stressed that people who do not have phenylketonuria are not at

risk. The company said that consumers with phenylketonuria who already purchased

these products can exchange their product for a " comparable Benadryl product " or

get a full refund.

The company expects to correct the labeling error within 4 to 6 weeks,

Pfizer spokesman Bob Fauteux told Reuters Health. Fauteux also noted that the

firm is looking into the cause of the mislabeling, but he would not disclose

further details of the investigation.

Phenylalanine is one of the ingredients in aspartame, an artifical

sweetener that Pfizer uses to make its Fastmelt products.

In a statement, Pfizer said it has told the US Food and Drug

Administration of the action and that it would enlist the help of

phenylketonuria organizations to notify patients of the potential health risk.

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