Grove Pharmaceuticals Recalls Nystatin Oral Suspension and Generlac Solution
July 27, 1999
Morton Grove, IL (SafetyAlerts) - The Food and Drug
Administration (FDA) today reported that Morton Grove Pharmaceuticals, Inc. is recalling
Nystatin Oral Suspension and Generlac Solution because of microbial contamination
This is the first public notice
issued by the FDA.
a) Nystatin Oral Suspension, USP,
100,000 units per Ml, Fruit Flavored, Rx in 2 ounce and 1 pint units, used for the
treatment of candidiasis of the oral cavity, under the Morton Grove, NDC #60432-537-16
& 60432-537-60, and Schein labels, NDC #0364-2075-58;
b) Generlac Solution (Lactulose Solution, USP), 10g/15Ml, for oral
or rectal administration, Rx in one pint (473 Ml) containers, an Rx oral colonic acidifier
for the prevention and treatment of portal-systemic encephalopathy, under the Morton Grove
label. NDC #60432-038-16.
a) 21533, 21720, 21776, 22118, 22325, 21616 and 22279;
a) Morton Grove Pharmaceuticals, Inc., Morton Grove, Illinois;
b) Morinaga Milk Industry Company, Ltd., Tokyo, Japan.
Morton Grove Pharmaceuticals, Inc., Morton Grove, Illinois, by letter dated June
14, 1999. Firm-initiated recall ongoing.
a) 26,136 pints and 50,263 2-fluid ounce bottles were distributed;
b) 21,105 pints were distributed; firm estimated that 10 percent of product
remained on market at time of recall initiation.