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SafetyAlerts
December 26, 2000

Suphedrine Cold & Allergy Tablets

Carson, CA (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Leiner Health Products is recalling its Suphedrine Cold & Allergy Tablets because of failure to manufacture as per validated method -- (reduced blend time and
excessive ingredient amount).

This is the first public notice of this Class III recall issued by FDA.

PRODUCT
Suphedrine Cold & Allergy Tablets (Pseudoephedrine HCl 60 mg & Chlorpheniramine Maleate 4 mg), in 24-tablet units, OTC.

Recall #D-061-1.

CODE
Lot #0032996.

MANUFACTURER
Leiner Health Products, Wilson, North Carolina.

RECALLED BY
Leiner Health Products, Carson, California, by letter on November 30, 2000. Firm-initiated recall ongoing.

DISTRIBUTION
Arkansas.

QUANTITY
1,147,392 tablets were distributed.

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

Notice of this product warning was sent via email to SafetyAlerts subscribers December 26, 2000.  For more information regarding the SafetyAlerts free email alert service please click here.

 
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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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.