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SafetyAlerts
November 21, 2000

Zagam® Tablets Recalled

First public notice issued by FDA of 'completed recall'...

Sugar Land, TX (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Bertek Pharmaceuticals, Inc. is recalling certain Zagam® Tablets because of dissolution failure (6 months stability station testing).

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

PRODUCT
Zagam(r) Tablets (Sparfloxacin), 200 mg, in 55-count bottles, Rx broad spectrum antimicrobial agent.
NDC #62794-011-55.

Recall #D-016-1.

CODE
Lot #MN4062 EXP 11/01.

MANUFACTURER
Aventis Pharma Ltd., Republic of Ireland.

RECALLED BY
Bertek Pharmaceuticals, Inc., Sugar Land, Texas, by letter on June 1, 2000, followed by telephone and fax on June 7, 2000. Firm-initiated recall **complete.

**Completed recall: While the FDA has completed processing of this particular recall, it does not mean this particular product has been fully accounted for.

DISTRIBUTION
Nationwide.

QUANTITY
105 bottles were distributed; firm estimates none remains on the market.

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 November 21, 2000.  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.