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February 23, 2000

SmithKline Beecham, Consumer Health, Recalls Extra Strength Panadol PM Caplets

Parsippany, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that SmithKline Beecham, Consumer Health, is recalling certain Extra Strength Panadol PM Caplets because glass particles were found in bulk diphenhydramine used in manufacturing.

The recalled Extra Strength Panadol is sold over-the-counter in bottles of 36 and 50 caplets and dispenser cartons of two caplets per pack.

The recalled product bears the Lot Numbers of PA033SH1, PA033SH2, PA027SJ2, PA083SH1, PA034SH1, PA035SH, PA098SH1 PA036SH1, PA032SH1, PA027SJ4 and PA028SJ1.  The EXP date for all lots is 07/2001.

According to the company, about 171,850 caplets, distributed in Puerto Rico, have yet to be recovered.  SmithKline Beecham has stated that almost 75% of the recalled product has been recovered.

This ongoing Class II recall was initiated by SmithKline Beecham, by hand delivered letter beginning on September 27, 1999.  This is the first public notice issued by the FDA.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.
FDA Recall #d-215

Notice of this product warning was sent via email to SafeMail subscribers February 23, 2000.

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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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.