April 4, 2001FDA First Notice: Leiner Health
Products, Inc. Recalls Maximum Strength Sinus Tablets
CA (SafetyAlerts) - The Food and
Drug Administration (FDA) said today that Leiner Health Products, Inc. has recalled
certain Maximum Strength Sinus Tablets because of subpotency and dissolution failures at
12 months of expiry.
This is the first public notice of
this Class III
recall issued by FDA.
(OTC) Maximum Strength Sinus Tablets (Acetaminophen 500 mg, Pseudoephedrine HCL
30mg, Chlorpheniramine Maleate 2 mg 24 counts.
Lot RM0260 (Bulk Lot Numbers 9046800, 9046801, 9046545, 9046546, 9068812, 9070507,
9070505, 9082222, 9082226, 9082225, 9093966, 9105984, 9105986, 0022054).
Contract Pharmacal Corp., Hauppauge, NY.
Leiner Health Products, Inc., Carson, CA. by letter on 1/15/01. Firm-initiated recall
AR and OH.
883,493 units packaged with 798,580 units distributed.
Questions concerning this recall may be directed
to the FDA at 1-888-INFO-FDA.