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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
March 24, 1999

PRODUCT
Naturade Children's Cough Syrup, OTC, (Glyceryl Guaiacolate(Guaifenesin)) 150 mg/15 ml, in 4 ounce and 8 ounce bottles. Recall #D-144-9.

CODE
Lot #I44047 EXP 9/99.

MANUFACTURER
Irenda Corporation, Los Angeles, California.

RECALLED BY
Naturade, Inc., Paramount, California, by letter dated March 10,1999. Firm-initiated recall ongoing.

DISTRIBUTION
Arizona, California, Colorado, Connecticut, Iowa, Illinois,Indiana, Missouri, New Hampshire, New Jersey, New York, Pennsylvania, Washington state, Wisconsin.

QUANTITY
7,356 4-ounce bottles and 984 8-ounce bottles weredistributed.

REASON
Mislabeling - The directions for children 2 to under 6 years ofage indicate dosage of 1 (one) tablespoon every 4 hours instead of the correct 1 (one) teaspoon every 4 hours.

 

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.