Leiner Health Products Inc. Recalls Acetaminophen Caplets

Carson, CA (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Leiner Health Products, Inc. has recalled certain Acetaminophen Caplets because the labeling incorrectly declared an extended expiration date.

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

PRODUCT
OTC) Acetaminophen Caplets, Extra Strength, 500 mg, 24, 50,100, 120, 175, and 500 count.

Recall #D-152-1.

CODES:
Lot Number 1281 (Bulk Lot Numbers W9071027R, W9071028R, W9081167R, W9081168R, W9091370R, W9101447R, W0020276R)

Lot Numbers: 0010027, 0019523, 0044473, 0044390, 0044393, 0044641, 0044642, 0044643, 0044644, 0054814, 0055201, 0055202, 0055203, 0055204, 0055959, 0055960, 0067254, 0067255, 9082276, 9082277, 9082278, 9082280, 9082281, 9082282, 9082284, 9082285, 9082320, 9082321, 9082322, 9082323, 9093579, 9093579, 9094484, 9094485, 9094486, 9094487, 9094488, 9094490, 9094491, 9094492, 9094493, 9094494, 9094582, 9094583, 9094586, 9094588, 9094591, 9094592, 9094593, 9094705, 9105451, 9105857, 9106368, 9106369, 9106370, 9106371, 9106372, 9106375, 9106380, 9106385, 9106388, 9106391, 9106395, 9116914, 9117201, 9117217, 9117218, 9117223, 9117225, 9117227, 9117228, 9117230, 9117365, 9128851.

MANUFACTURER:
Leiner Health Products, Inc., Wilson, NC .

RECALLED BY:
Leiner Health Products, Inc., Carson, CA, by letter on January 15, 2001. Firm-initiated recall ongoing.

DISTRIBUTION:
AR, CT, FL, IN, MA, MN, NJ, NY, NC, OH, PA, and TN.

QUANTITY:
376,801 units were packaged and 362,953 units 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 April 12, 2001.  For more information regarding the SafetyAlerts free email alert service please click here.