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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
May 5, 1999

Solvay Pharmaceuticals Inc. Recalls Duphalac

Marietta, GA (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Solvay Pharmaceuticals Inc. is recalling Duphalac the product bears the generic name Lactose Solution, USP, rather than Lactulose Solution, USP and is incorrectly labeled to contain benzoic acid.

PRODUCT
Duphalac (Lactulose Solution, USP), 20 g/30mL, Rx in unit dose cups.

Recall #D-206-9.

CODE
Lot #89901.

MANUFACTURER
Solvay Pharmaceuticals Inc., Marietta, Georgia.

RECALLED BY
Manufacturer, by letter on April 8, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
2,088 units were distributed.

 

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.