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Safety Alerts
July 27, 1999

Morton Grove Pharmaceuticals Recalls Nystatin Oral Suspension and Generlac Solution

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 (acinetobacter baumanii).

This is the first public notice issued by the FDA.

PRODUCT
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.

Recall #D-184/285-9.

CODE
Lot numbers:
a) 21533, 21720, 21776, 22118, 22325, 21616 and 22279;
b) 21767.

MANUFACTURER
a) Morton Grove Pharmaceuticals, Inc., Morton Grove, Illinois;
b) Morinaga Milk Industry Company, Ltd., Tokyo, Japan.

RECALLED BY
Morton Grove Pharmaceuticals, Inc., Morton Grove, Illinois, by letter dated June 14, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
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.

 

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.