January 18, 2000
Updated June 13, 2000Schein
Pharmaceuticals Recalls Quinidine Gluconate Extended Release Tablets
Brewster, NY (SafetyAlerts) - The Food and Drug
Administration (FDA) today reported that Schein Pharmaceuticals is recalling 324 mg
Quinidine Gluconate Extended Release Tablets because the product may not meet dissolution
specification over labeled expiration period.
The recalled product, manufactured by
Danbury Pharmaceuticals, Inc is used as an antimalaria and antiarrhythmic and was
distributed in in 100, 250, and 500-tablet bottles. The product can be identified as
New lot numbers added on
June 13, 2000 - Lot Numbers C8E1069 and C8F1172.
NDC-0364-0604-01 bottles of
C8D0669 (04/00), C8D0670 (04/00), C8E1066 (06/00), C8E1068 (06/00), C8F1173
(07/00), C8F1174 (07/00), C8F1234 (08/00)
NDC-0364-0604-04 bottles of
C8B0265 (04/00), C8B0266 (04/00), C8D0671 (04/00), C8D0672 (04/00), C8D0673
(04/00), C8E1070 (06/00), C8E1071 (06/00), C8F1170 (07/00), C8F1171 (07/00), C8F1235
NDC-0364-0604-05 bottles of
C8B0263 (04/00), C8B0264 (04/00), C8E1067 (06/00).
According to FDA, over 29,000 bottles
were distributed Nationwide.
This ongoing Class III recall
was initiated by Schein Pharmaceuticals by letter dated December 22, 1999. This is
the first public notice issued by the FDA.
Questions concerning this recall may
be directed to the FDA at 1-888-INFO-FDA.
FDA Recall #D-203-0
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