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SafetyAlerts
November 21, 2000

Duphalac® Lactulose Solution Recalled

Marietta, 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 (stability data).

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

PRODUCT
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.

Recall #D-024/025-1.

CODE
All lots within expiration date.

MANUFACTURER
Solvay Pharmaceuticals, Inc., Baudette, Minnesota.

RECALLED BY
Solvay Pharmaceuticals, Inc., Marietta, Georgia, by letter on August 23, 2000. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
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.

 
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.