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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

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

PRODUCT
Gamma-G Night Time Formula powder, (2(3H)-Furanone), OTC, labeled as a nutritional supplement for oral use to induce sleep, in 200 gram bottles. Recall #D-118-9.

CODE
All lot numbers.

MANUFACTURER
Undetermined.

RECALLED BY
Conan Corporation, doing business as Castlewood Nutritional Services, Jefferson, Ohio (distributor), by telephone beginning on January 20, 1999, followed by fax on January 22, 1999. Firm-initiated recall ongoing. See also FDA talk paper T99-05, January 21, 1999.

DISTRIBUTION
Texas, North Carolina, Florida.

QUANTITY

Approximately 3,500 bottles were distributed.

REASON
Product is an unapproved new drug.

 

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.