November 21, 2000Zagam® Tablets Recalled
public notice issued by FDA of 'completed recall'...
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
This is the first public notice of
this Class II
issued by FDA.
Zagam(r) Tablets (Sparfloxacin), 200 mg, in 55-count bottles, Rx broad
spectrum antimicrobial agent.
Lot #MN4062 EXP 11/01.
Aventis Pharma Ltd., Republic of Ireland.
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.
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.
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