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SafetyAlerts
May 11, 2001

TorPharm Recalls Cimetidine Tablets

Etobiocoke, Ontario (SafetyAlerts) - The Food and Drug Administration (FDA) said today that TorPharm, A Division of Apotex has recalled two lots of Cimetidine Tablets because Lot 90570A failed the 12 month test station dissolution test at room temperature conditions, and Lot 00197A went to S3 testing during followup testing of 35 lots of the same age range.

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

PRODUCT
Cimetidine Tablets, USP, 800 mg. In bottles of 100 tablets, NDC #60505-0021-2, ANDA 74-890.

Recall #D-189-1.

CODE:
Lot 90570A and Lot 00197A.

MANUFACTURER:
TorPharm, A Division of Apotex, Etobiocoke, Ontario, Canada.

RECALLED BY:
Manufacturer, by letters dated 4/10/01. Firm-initiated recall ongoing.

DISTRIBUTION:
FL, MI, CA, IN, TN, NY, IL, TX, WI, MN and KY.

QUANTITY:
2013 bottles of 100 tablets.

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.