May 11, 2001TorPharm Recalls Cimetidine
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.
Cimetidine Tablets, USP, 800 mg. In bottles of 100 tablets, NDC #60505-0021-2,
Lot 90570A and Lot 00197A.
TorPharm, A Division of Apotex, Etobiocoke, Ontario, Canada.
Manufacturer, by letters dated 4/10/01. Firm-initiated recall ongoing.
FL, MI, CA, IN, TN, NY, IL, TX, WI, MN and KY.
2013 bottles of 100 tablets.
Questions concerning this recall may be directed
to the FDA at 1-888-INFO-FDA.