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SafetyAlerts
July 19, 2001

FDA First Notice: Equate,   Bi-Mart and Western Family Recalled

Carson, CA (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Leiner Health Products is recalling certain lot(s) of Extra strength enteric-coated aspirin tablets because the dissolution test failed.

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

PRODUCT:
Extra strength enteric-coated aspirin tablets, 500 mg in 60 tablet bottles, packaged under three labels as follows:

Equate (Walmart)
Lot number: 0044685
Expiration: 3/01

Bi-Mart (Eugene, OR)
Lot number: 8E01222
Expiration: 3/01

Western Family (Portland, OR)
Lot number: 8E01222
Expiration: 3/01

RECALL NUMBER:
D-260-1

MANUFACTURER
INK International, Hauppauge, NY 11788

RECALL BY:
Leiner Health Products, Carson, CA (Lot 8E01222) and Leiner Health Products, Largo, Fl. (Lot 0044685)

FIRM INITIATED RECALL:
Complete - *NOTE: FDA states 'completed recall' indicates the company has removed all affected product from store shelves,  it does not necessarily mean this particular product lot, or codes, have been fully accounted for.

DISTRIBUTION:
AR and OR

QUANTITY:
Equate Label (lot 0044685) = 5,328 bottles
Bi-Mart Label (lot 8E01222) = 1,728 bottles
Western Family Label (lot 8E01222) = 8,136 bottles

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 July 19, 2001.  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.