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June 27, 2000

UriTAB, PremeTAB, PrevenTAC and   SomaTAC Recalled

Farmingdale, NY (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Olus Laboratories is conducting a recall of certain UriTAB, PremeTAB, PrevenTAC and  SomaTAC because the products are unapproved new drugs.

The recalled details for each product are:

a) UriTAB(tm) Caplets (Phenazopyridine HCL 95 mg), 30 caplet box, OTC, for urinary pain relief. This product was distributed in Connecticut, New Jersey and Oregon. (Lot #J15460)

b) PremeTAB(tm) Tablets (Acetaminophen 500 mg, Pamabrom 25mg, Pyrilamine Maleate 15 mg) 15 tablet units, OTC, for use with premenstrual discomfort.  This product was distributed in Connecticut, New Jersey, New York and Oregon (Lot #J15466)

c) PrevenTAC(tm) Caplets (Aspirin 81 mg), 30 caplets, OTC, to help in the prevention of heart disease and heart attacks. This product was distributed in Connecticut, Florida, Georgia, New Jersey, New York, North Carolina, Oregon, Pennsylvania and Texas (Lot #J16148)

d) SomaTAC(tm) Caplets (Diphenhydramine Hydrochloride 50 mg), 15 caplets, OTC, helps relieve occasional sleeplessness due to stress, anxiety, restlessness, and irritability. This product was distributed in Connecticut, New Jersey, Oregon. (Lot #J15548)

According to FDA, over 850 cases were distributed

This ongoing Class II recall was initiated by the company, by fax on February 21, 2000, and by telephone on March 22, 2000. 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.
Recall #d-413/416-0

Notice of this product warning was sent via email to SafeMail subscribers June 27, 2000.

Selected Recent Recalls

Health Professional:

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

How many did you hear about?

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