December 26, 2000Suphedrine Cold & Allergy
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.
Suphedrine Cold & Allergy Tablets (Pseudoephedrine HCl 60 mg &
Chlorpheniramine Maleate 4 mg), in 24-tablet units, OTC.
Leiner Health Products, Wilson, North Carolina.
Leiner Health Products, Carson, California, by letter on November 30, 2000. Firm-initiated
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.
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