November 21, 2000Duphalac® Lactulose Solution
GA (SafetyAlerts) - The Food and
Drug Administration (FDA) said today that Solvay Pharmaceuticals, Inc. is recalling
certain Duphalac® Lactulose Solution lots because of a firm withdrawal of application
This is the first public notice of
this Class III
issued by FDA.
a) Duphalac(r) (Lactulose Solution, USP), 10 g/15mL, in 8, 16, and
32-fluid ounce units;
b) Duphalac(r) (Lactulose Solution, USP), 20 g/30mL, in 30mL unit dose cups.
All lots within expiration date.
Solvay Pharmaceuticals, Inc., Baudette, Minnesota.
Solvay Pharmaceuticals, Inc., Marietta, Georgia, by letter on August 23, 2000.
Firm-initiated recall ongoing.
1,814,103 units were distributed.
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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