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SafetyAlerts
April 12, 2001

GENEVA Pharmaceuticals Recalls Amoxycillin Capsules

Broomfield, CO (SafetyAlerts) - The Food and Drug Administration (FDA) said today that GENEVA Pharmaceuticals has recalled certain Amoxycillin capsules because the drug was distributed prior to approval of manufacturing changes.

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

PRODUCT
Geneva Pharmaceuticals Amoxycillin 250 mg capsules,
Recall #D-166-1 and Amoxycillin 500 mg capsules, Recall #D-167-1.
NDC #00781-2020-01 (250 mg 100's);
NDC #00781-2020-05 (250 mg 500's);
NDC #00781-2613-01 (500 mg 100's);
NDC #00781-2613-05 (500 mg 500's).

CODES:
Lot Numbers and exp dates:
107283 05/02
107284 05/02
107285 05/02
107297 06/02
108375 09/02
108376 09/02
108377 09/02
108378 09/02
108379 09/02
108865 11/02
108866 11/02
108867 11/02
108868 10/02
109430 11/02.

MANUFACTURER:
Biochemie GmbH, Tyrol, Austria.

RECALLED BY:
GENEVA Pharmaceuticals, Broomfield, CO, by letter on
March 13, 2001. Firm-initiated recall ongoing.

DISTRIBUTION:
CO, FL, NY, OK, VA.

QUANTITY:
7,495,900/ 250mg capsules, 14,859,600/ 500mg capsules.

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 April 12, 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.