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SafetyAlerts
April 4, 2001

FDA First Notice: Leiner Health Products, Inc. Recalls Maximum Strength Sinus Tablets

Carson, 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.

PRODUCT
(OTC) Maximum Strength Sinus Tablets (Acetaminophen 500 mg, Pseudoephedrine HCL 30mg, Chlorpheniramine Maleate 2 mg 24 counts.

Recall #D-150-1.

CODE:
Lot RM0260 (Bulk Lot Numbers 9046800, 9046801, 9046545, 9046546, 9068812, 9070507, 9070505, 9082222, 9082226, 9082225, 9093966, 9105984, 9105986, 0022054).

MANUFACTURER:
Contract Pharmacal Corp., Hauppauge, NY.

RECALLED BY:
Leiner Health Products, Inc., Carson, CA. by letter on 1/15/01. Firm-initiated recall ongoing.

DISTRIBUTION:
AR and OH.

QUANTITY:
883,493 units packaged with 798,580 units distributed.

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

 
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.