Pharmaceuticals Inc. Recalls Duphalac
FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
May 5, 1999
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.
Duphalac (Lactulose Solution, USP), 20 g/30mL, Rx in unit dose cups.
Solvay Pharmaceuticals Inc., Marietta, Georgia.
Manufacturer, by letter on April 8, 1999. Firm-initiated recall ongoing.
2,088 units were distributed.