February 23, 2000SmithKline 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.
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