Schein 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 follows:

New lot numbers added on June 13, 2000 - Lot Numbers C8E1069 and C8F1172.

NDC-0364-0604-01 bottles of 100's
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 250's
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 (08/00)

NDC-0364-0604-05 bottles of 500's
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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