Re: TorPharm Recalls Cimetidine Tablets

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SafetyAlerts

May 11, 2001TorPharm Recalls Cimetidine Tablets

Etobiocoke, Ontario (<A

HREF= " http://www.safetyalerts.com/Default.htm " >SafetyAlerts</A>) - 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 <A

HREF= " http://www.safetyalerts.com/rcls/class_exp.htm " >Class III</A> 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.