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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
April 28, 1999

SSS/Pfeiffer Pharmaceuticals is Recalling Kaodene for Mislabeling

PRODUCT
Kaodene non-narcotic liquid for upset stomach and diarrhea, (30ml Kaolin 3888 mg, Pectin 194.4 mg ...), OTC in 4 fl. oz. bottles. NDC #0927-0421-12.
Recall #D-193-9.

CODE
Lot #52201.

MANUFACTURER
SSS/Pfeiffer Pharmaceuticals, Atlanta, Georgia.

RECALLED BY
Manufacturer, by letter on March 18, 1999. Firm- initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
3,467 units were distributed; firm estimated that 1,500 units remained on market at time of recall initiation.

REASON
Mislabeling - Immediate bottle label declares incorrect lot number and expiration date (52201 EXP 5 98) bottom of bottle bears correct lot number and expiration date (82201 EXP 6/00).________

 

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.